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Hainan Huluwa Pharmaceutical Group Co., Ltd.

Check drug filings and source records for this company-name string.

Listed by the company name as recorded in the source, without merging affiliated entities.

Page reference 353a0e2ab8

Complete CDE snapshot
2026/11/12 06:41
Matching scope
Loaded public-source records only

These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/12 06:41.

Drug filings

98 acceptance records as first applicant, grouped into 68 source drug names. Source data as of 2026/11/12 06:41.

Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.

小儿化积颗粒 · No verified English name 1 records · Latest accepted 2026/06/26

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZS2600034New drug2026/06/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
盐酸氨溴索口溶膜 · No verified English name 1 records · Latest accepted 2026/02/13

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHS2600030New drug2026/02/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Eldecalcitol Soft Capsules 2 records · Latest accepted 2026/02/10

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600421Generic2026/02/10Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2600420Generic2026/02/10Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Valsartan and Amlodipine Tablets(I) 2 records · Latest accepted 2025/12/19

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502546Supplement2025/12/19Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2200982Generic2022/06/30Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Rosuvastatin Calcium and Ezetimibe Tablets (I) 1 records · Latest accepted 2025/10/16

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503700Generic2025/10/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Acetylcysteine Granules 2 records · Latest accepted 2025/09/28

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503530Generic2025/09/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2503529Generic2025/09/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Acetylcysteine Injection 1 records · Latest accepted 2025/09/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503497Generic2025/09/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
小儿胆青双解颗粒 · No verified English name 1 records · Latest accepted 2025/08/12

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZL2500065New drug2025/08/12Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
小儿肺热咳喘颗粒 · No verified English name 2 records · Latest accepted 2025/07/03

New drug · 1Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZL2500043New drug2025/07/03Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYZB2200631Supplement2022/06/21Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
布瑞哌唑口溶膜 · No verified English name 2 records · Latest accepted 2025/06/24

New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHS2500069New drug2025/06/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CXHS2500068New drug2025/06/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
枸橼酸西地那非口溶膜 · No verified English name 1 records · Latest accepted 2025/04/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501557Generic2025/04/25Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Azilsartan Medoxomil Potassium Tablets 2 records · Latest accepted 2025/04/07

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501311Generic2025/04/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2501310Generic2025/04/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
肺热咳喘颗粒 · No verified English name 1 records · Latest accepted 2025/03/27

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZL2500020New drug2025/03/27Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Esomeprazole Magnesium for Delayed-release Oral Suspension 1 records · Latest accepted 2025/02/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500780Generic2025/02/18Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Formoterol Fumarate Inhalation Solution 1 records · Latest accepted 2024/12/31

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404622Generic2024/12/31Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Naloxone Hydrochloride Injection 1 records · Latest accepted 2024/12/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404336Generic2024/12/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
头孢克肟颗粒 · No verified English name 1 records · Latest accepted 2024/11/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403992Generic2024/11/21Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Cefditoren Pivoxil Granules 4 records · Latest accepted 2024/10/31

Generic · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403686Generic2024/10/31Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2402029Generic2024/07/04Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2401101Generic2024/04/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2401100Generic2024/04/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Vonoprazan Fumarate Tablets 2 records · Latest accepted 2024/10/24

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403595Generic2024/10/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2403594Generic2024/10/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Ipratropium Bromide Inhalation Solution 4 records · Latest accepted 2024/09/11

Generic · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403032Generic2024/09/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2403031Generic2024/09/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2301288Generic2023/05/12Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2301287Generic2023/05/12Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules 2 records · Latest accepted 2024/08/09

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402544Generic2024/08/09Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2402543Generic2024/08/09Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Zoledronic Acid Concentrated Solution for Injection 1 records · Latest accepted 2024/07/10

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402109Generic2024/07/10Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
易黄颗粒 · No verified English name 1 records · Latest accepted 2024/07/04

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZS2400025New drug2024/07/04Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
维生素K滴剂 · No verified English name 1 records · Latest accepted 2024/07/04

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402022Generic2024/07/04Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Ceftazidime And Avibactam Sodium For Injection 1 records · Latest accepted 2024/06/07

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401725Generic2024/06/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
注射用头孢唑肟钠 · No verified English name 2 records · Latest accepted 2024/05/18

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450281Supplement2024/05/18Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2450280Supplement2024/05/18Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Arformoterol Tartrate Inhalation Solution 1 records · Latest accepted 2024/05/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2400094Generic2024/05/14Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Sacubitril Valsartan Sodium Tablets 2 records · Latest accepted 2024/05/13

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401434Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2401433Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Gadobutrol Injection 2 records · Latest accepted 2024/05/13

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401437Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2401436Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Omeprazole Enteric Capsules 2 records · Latest accepted 2024/04/12

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450229Supplement2024/04/12Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2350718Supplement2023/09/21Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
小儿康颗粒 · No verified English name 2 records · Latest accepted 2024/03/30

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2400544Supplement2024/03/30Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYZB2400543Supplement2024/03/30Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Cefotaxime Sodium For Injection 2 records · Latest accepted 2024/02/08

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450118Supplement2024/02/08Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2450117Supplement2024/02/08Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Olprinone Hydrochloride Injection 1 records · Latest accepted 2023/12/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303511Generic2023/12/19Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Lansoprazole For Injection 1 records · Latest accepted 2023/11/28

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350878Supplement2023/11/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Oseltamivir Phosphate For Oral Suspension 1 records · Latest accepted 2023/11/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303053Generic2023/11/08Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
二甲双胍恩格列净片(I) · No verified English name 1 records · Latest accepted 2023/11/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302981Generic2023/11/02Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Salbutamol Sulfate Inhalation Solution 1 records · Latest accepted 2023/10/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302772Generic2023/10/14Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Compound Ipratropium Bromide Solution For Inhalation 1 records · Latest accepted 2023/10/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302747Generic2023/10/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Calcitriol Soft Capsules 1 records · Latest accepted 2023/10/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302755Generic2023/10/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Cefdinir Capsules 1 records · Latest accepted 2023/10/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302701Generic2023/10/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
盐酸左沙丁胺醇雾化吸入溶液 · No verified English name 1 records · Latest accepted 2023/08/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302228Generic2023/08/22Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
头孢丙烯干混悬剂 · No verified English name 1 records · Latest accepted 2023/08/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302198Generic2023/08/19Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Esomeprazole Sodium for Injection 2 records · Latest accepted 2023/08/11

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302081Generic2023/08/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2302080Generic2023/08/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
元胡止痛片 · No verified English name 1 records · Latest accepted 2023/07/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2301403Supplement2023/07/29Hainan Huluwa Pharmaceutical Group Co., Ltd.; Cheng De Xin Ai Min Pharmaceutical Co., Ltd. romanizedCDE ↗
小儿感冒颗粒 · No verified English name 1 records · Latest accepted 2023/07/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2301402Supplement2023/07/29Hainan Huluwa Pharmaceutical Group Co., Ltd.; Cheng De Xin Ai Min Pharmaceutical Co., Ltd. romanizedCDE ↗
LPC-006口溶膜 · No verified English name 2 records · Latest accepted 2023/06/30

New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2300720New drug2023/06/30Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CXHL2300719New drug2023/06/30Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Oseltamivir Phosphate Capsules 1 records · Latest accepted 2023/06/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2301713Generic2023/06/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Brivaracetam Solution for Injection 1 records · Latest accepted 2023/06/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2300072Generic2023/06/01Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
银翘解毒颗粒 · No verified English name 1 records · Latest accepted 2023/05/05

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2300747Supplement2023/05/05Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
肠炎宁颗粒 · No verified English name 1 records · Latest accepted 2023/04/28

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2300711Supplement2023/04/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Ibuprofen Granules 2 records · Latest accepted 2023/03/29

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350300Supplement2023/03/29Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2202222Supplement2022/12/13Hainan Huluwa Pharmaceutical Group Co., Ltd.; Shenyang Fu Ning Pharma Co., Ltd. romanizedCDE ↗
Acetylcysteine Solution For Inhalation 1 records · Latest accepted 2023/03/16

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300807Generic2023/03/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Tenofovir alafenamide Fumarate Tablets 1 records · Latest accepted 2023/01/29

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300226Generic2023/01/29Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
硫酸特布他林雾化吸入用溶液 · No verified English name 1 records · Latest accepted 2023/01/29

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300231Generic2023/01/29Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Argatroban Injection 1 records · Latest accepted 2023/01/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300184Generic2023/01/19Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Arginine and Ibuprofen Granules 2 records · Latest accepted 2023/01/17

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300159Generic2023/01/17Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2300158Generic2023/01/17Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Desloratadine Tablets 1 records · Latest accepted 2022/12/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2202040Generic2022/12/08Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Montelukast Sodium Chewable Tablets 2 records · Latest accepted 2022/10/09

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201672Generic2022/10/09Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHS2201671Generic2022/10/09Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Bromhexine Hydrochloride Injection 1 records · Latest accepted 2022/09/09

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201492Generic2022/09/09Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Peramivir Injection 1 records · Latest accepted 2022/08/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201341Generic2022/08/19Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
盐酸溴己新雾化吸入溶液 · No verified English name 1 records · Latest accepted 2022/07/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2200056Generic2022/07/11Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Aztreonam For Injection 3 records · Latest accepted 2022/04/26

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250243Supplement2022/04/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2250242Supplement2022/04/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2250241Supplement2022/04/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
头孢地尼颗粒 · No verified English name 1 records · Latest accepted 2022/02/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200370Generic2022/02/28Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Cefminox Sodium for Injection 1 records · Latest accepted 2021/12/02

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2151046Supplement2021/12/02Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Ceftazidime for Injection 3 records · Latest accepted 2021/11/16

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2151019Supplement2021/11/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2151018Supplement2021/11/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2151017Supplement2021/11/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Cefoxitin Sodium for Injection 2 records · Latest accepted 2021/10/26

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150948Supplement2021/10/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
CYHB2150947Supplement2021/10/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Omeprazole Sodium for Injection 1 records · Latest accepted 2021/01/06

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150004Supplement2021/01/06Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Azithromycin For Injection 1 records · Latest accepted 2021/01/06

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150003Supplement2021/01/06Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗

Changes in the last 90 days

2 events from 2026/08/15 to 2026/11/12. CDE data as of 2026/11/12 06:41; NMPA data as of 2026/11/10 18:31.

This source was last successfully updated at 2026/11/10 18:31; current coverage may be incomplete.

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

No longer listed under review: 2 applications

  1. 2026/11/06No longer listed under review

    Sacubitril Valsartan Sodium Tablets

    CYHS2401434

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2024/05/13

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/06No longer listed under review

    Sacubitril Valsartan Sodium Tablets

    CYHS2401433

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2024/05/13

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗

Under review

17 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/12 06:41.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
小儿化积颗粒 · No verified English name CXZS2600034New drug2026/06/26Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
盐酸氨溴索口溶膜 · No verified English name CXHS2600030New drug2026/02/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Eldecalcitol Soft Capsules CYHS2600421Generic2026/02/10Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Eldecalcitol Soft Capsules CYHS2600420Generic2026/02/10Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Rosuvastatin Calcium and Ezetimibe Tablets (I) CYHS2503700Generic2025/10/16Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Acetylcysteine Injection CYHS2503497Generic2025/09/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
布瑞哌唑口溶膜 · No verified English name CXHS2500068New drug2025/06/24Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
枸橼酸西地那非口溶膜 · No verified English name CYHS2501557Generic2025/04/25Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2501311Generic2025/04/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2501310Generic2025/04/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Esomeprazole Magnesium for Delayed-release Oral Suspension CYHS2500780Generic2025/02/18Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Formoterol Fumarate Inhalation Solution CYHS2404622Generic2024/12/31Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
头孢克肟颗粒 · No verified English name CYHS2403992Generic2024/11/21Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
维生素K滴剂 · No verified English name CYHS2402022Generic2024/07/04Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Ceftazidime And Avibactam Sodium For Injection CYHS2401725Generic2024/06/07Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Gadobutrol Injection CYHS2401437Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗
Gadobutrol Injection CYHS2401436Generic2024/05/13Hainan Huluwa Pharmaceutical Group Co., Ltd.CDE ↗

Catalogue holder records

40 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/12 06:38. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Naloxone Hydrochloride InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202650742026/07/08Generic approved under the new chemical-drug registration classificationCDE ↗
Zoledronic Acid Concentrated Solution for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202643762026/05/19Generic approved under the new chemical-drug registration classificationCDE ↗
Olprinone Hydrochloride InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202636612026/03/17Generic approved under the new chemical-drug registration classificationCDE ↗
Oseltamivir Phosphate For Oral SuspensionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202554552025/09/09Generic approved under the new chemical-drug registration classificationCDE ↗
Cefdinir CapsulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202552952025/09/02Generic approved under the new chemical-drug registration classificationCDE ↗
二甲双胍恩格列净片(I) · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202551882025/08/26Generic approved under the new chemical-drug registration classificationCDE ↗
Cefotaxime Sodium For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200432582025/07/15Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefotaxime Sodium For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200432572025/07/15Drug that passed quality-and-efficacy consistency evaluationCDE ↗
头孢丙烯干混悬剂 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202548002025/07/08Generic approved under the new chemical-drug registration classificationCDE ↗
注射用头孢唑肟钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H201733132025/05/19Drug that passed quality-and-efficacy consistency evaluationCDE ↗
注射用头孢唑肟钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H201733142025/05/19Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Arginine and Ibuprofen GranulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202538942025/04/15Generic approved under the new chemical-drug registration classificationCDE ↗
Lansoprazole For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202133182025/03/05Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Calcitriol Soft CapsulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202534742025/02/25Generic approved under the new chemical-drug registration classificationCDE ↗
Omeprazole Enteric CapsulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200663932025/01/17Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Esomeprazole Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202531422025/01/14Generic approved under the new chemical-drug registration classificationCDE ↗
Esomeprazole Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202531432025/01/14Generic approved under the new chemical-drug registration classificationCDE ↗
Oseltamivir Phosphate CapsulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202492912024/11/05Generic approved under the new chemical-drug registration classificationCDE ↗
Argatroban InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202492222024/10/29Generic approved under the new chemical-drug registration classificationCDE ↗
Omeprazole Enteric CapsulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200462722024/07/09Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Montelukast Sodium Chewable TabletsHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202439842024/06/11Not stated by sourceCDE ↗
Montelukast Sodium Chewable TabletsHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202439852024/06/11Not stated by sourceCDE ↗
Desloratadine TabletsHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202435672024/04/24Generic approved under the new chemical-drug registration classificationCDE ↗
Bromhexine Hydrochloride InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202435512024/04/24Generic approved under the new chemical-drug registration classificationCDE ↗
Ibuprofen GranulesHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H201330692024/02/26Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Peramivir InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202432302024/02/23Generic approved under the new chemical-drug registration classificationCDE ↗
头孢地尼颗粒 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202431512024/02/06Generic approved under the new chemical-drug registration classificationCDE ↗
Valsartan and Amlodipine Tablets(I)Hainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202345142023/11/21Generic approved under the new chemical-drug registration classificationCDE ↗
Cefminox Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200569442023/05/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Aztreonam For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H201132612023/05/22Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Aztreonam For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200595842023/05/22Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Aztreonam For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H201132622023/05/22Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ceftazidime for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200331162023/03/13Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ceftazidime for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200431242023/03/13Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ceftazidime for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200341792023/03/13Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefoxitin Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200731122023/01/17Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefoxitin Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200582212023/01/17Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Omeprazole Sodium for InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200591742021/11/23Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Azithromycin For InjectionHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H200649322021/11/19Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Tenofovir alafenamide Fumarate TabletsHainan Huluwa Pharmaceutical Group Co., Ltd.Hainan Huluwa Pharmaceutical Group Co., Ltd.国药准字H202443822024/07/09Generic approved under the new chemical-drug registration classificationCDE ↗

Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.

API registrations

34 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/12 06:40.

NameCompany / applicantRegistration numberStatusSource update dateView source
右莰醇 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20250001433I2026/01/27CDE ↗
克立硼罗 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20240001257I2024/12/04CDE ↗
富马酸福莫特罗 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20240000858I2024/08/21CDE ↗
单磷酸阿糖腺苷 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190009732A2026/02/04CDE ↗
兰索拉唑 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190008202A2024/07/11CDE ↗
更昔洛韦 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190007811A2024/07/09CDE ↗
硫普罗宁 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190007810A2024/07/09CDE ↗
盐酸伐昔洛韦 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190007809A2024/07/09CDE ↗
甘草酸二铵 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190007806A2024/07/09CDE ↗
头孢替唑钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006387A2024/07/16CDE ↗
帕米膦酸二钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006386A2024/07/16CDE ↗
磷酸依托泊苷 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006385A2024/07/11CDE ↗
葡萄糖酸钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006148A2024/07/17CDE ↗
甲磺酸左氧氟沙星 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190006074A2024/07/11CDE ↗
精氨酸阿司匹林 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190005845A2024/07/11CDE ↗
赖氨匹林 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190004433A2025/07/30CDE ↗
卡络磺钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002854A2024/07/11CDE ↗
奥扎格雷 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002853A2024/07/11CDE ↗
头孢米诺钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002452A2024/07/11CDE ↗
氟马西尼 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002451A2024/07/09CDE ↗
盐酸甲氯芬酯 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002450A2024/07/09CDE ↗
葡萄糖酸依诺沙星 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002449A2024/07/11CDE ↗
氨甲环酸 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002448A2024/07/16CDE ↗
尼麦角林 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002447A2024/07/11CDE ↗
盐酸雷莫司琼 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002446A2024/07/10CDE ↗
炎琥宁 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002445A2024/06/28CDE ↗
新鱼腥草素钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002444A2024/06/28CDE ↗
硫酸头孢匹罗 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002439A2024/07/09CDE ↗
头孢克肟 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002438A2024/07/11CDE ↗
头孢匹胺钠 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002436A2024/06/28CDE ↗
盐酸尼莫司汀 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002418A2024/07/10CDE ↗
氨曲南 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002417A2024/07/10CDE ↗
盐酸头孢吡肟 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190001361A2024/06/28CDE ↗
单磷酸阿糖腺苷 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20170001923A2026/02/04CDE ↗

Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.

Co-applicant records

0 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/12 06:41.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/12 06:41
Chemical-drug catalogue
Last successful update: 2026/11/12 06:38
Full API register
Last successful update: 2026/11/12 06:40
NMPA drug delivery notices
Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete

First index-page publication dates: — to —; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Listed by the company name as recorded in the source, without merging affiliated entities.

This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

Drugs with a verified official English name use that name only. Other drug names retain the Chinese source name marked No verified English name; names with a Chinese public page link to that page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized; Chinese company names are not displayed. Marked unverified drug names and original statutory reference numbers may appear in Chinese.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.