Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
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 3e7bd982e5
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/13 06:42.
Drug filings
33 acceptance records as first applicant, grouped into 21 source drug names. Source data as of 2026/11/13 06:42.
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.
Adenosine Injection 1 records · Latest accepted 2026/04/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600981 | Generic | 2026/04/28 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Propafenone Hydrochloride Injection 1 records · Latest accepted 2026/01/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600291 | Generic | 2026/01/28 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Azithromycin For Injection 2 records · Latest accepted 2025/10/18
Supplement · 1Generic · 1
Ozagrel Sodium Injection 3 records · Latest accepted 2025/09/02
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503227 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHS2503226 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHS2503225 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Bromhexine Hydrochloride Injection 1 records · Latest accepted 2024/08/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402789 | Generic | 2024/08/27 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Levofloxacin Injection 1 records · Latest accepted 2024/04/12
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401087 | Generic | 2024/04/12 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Clindamycin Injection 2 records · Latest accepted 2024/02/27
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450151 | Supplement | 2024/02/27 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHB2450150 | Supplement | 2024/02/27 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Metoprolol Tartrate Injection 2 records · Latest accepted 2023/12/12
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350928 | Supplement | 2023/12/12 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHB2350927 | Supplement | 2023/12/12 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Diquafosol Sodium Eye Drops 1 records · Latest accepted 2023/10/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302726 | Generic | 2023/10/13 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Voriconazole for Injection 2 records · Latest accepted 2023/09/26
Generic · 2
Peramivir Injection 1 records · Latest accepted 2023/08/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302082 | Generic | 2023/08/11 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Doxofylline Injection 2 records · Latest accepted 2023/05/30
Generic · 2
Ropivacaine hydrochloride injection 4 records · Latest accepted 2023/05/23
Generic · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301388 | Generic | 2023/05/23 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHS2301387 | Generic | 2023/05/23 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHS2301386 | Generic | 2023/05/23 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| CYHS2301385 | Generic | 2023/05/23 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Oral Solution 1 records · Latest accepted 2023/04/20
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301106 | Generic | 2023/04/20 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Parecoxib Sodium for Injection 2 records · Latest accepted 2022/09/07
Generic · 2
Esmolol Hydrochloride Injection 1 records · Latest accepted 2022/06/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200929 | Generic | 2022/06/22 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Ornidazole Injection 2 records · Latest accepted 2022/05/31
Generic · 2
Moxifloxacin Hydrochloride Eye Drops 1 records · Latest accepted 2022/04/21
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200621 | Generic | 2022/04/21 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Argatroban Injection 1 records · Latest accepted 2021/11/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102057 | Generic | 2021/11/24 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Solution For Inhalation 1 records · Latest accepted 2021/06/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101349 | Generic | 2021/06/25 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Injection 1 records · Latest accepted 2021/05/17
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101164 | Generic | 2021/05/17 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
0 events from 2026/08/16 to 2026/11/13. CDE data as of 2026/11/13 06:42; NMPA data as of 2026/11/12 18:32.
This source was last successfully updated at 2026/11/12 18:32; 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 matching records were found in the currently loaded source data; coverage dates are listed below.
Under review
5 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Adenosine Injection | CYHS2600981 | Generic | 2026/04/28 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Propafenone Hydrochloride Injection | CYHS2600291 | Generic | 2026/01/28 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Ozagrel Sodium Injection | CYHS2503227 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Ozagrel Sodium Injection | CYHS2503226 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Ozagrel Sodium Injection | CYHS2503225 | Generic | 2025/09/02 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
23 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/13 06:39. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Bromhexine Hydrochloride Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20256398 | 2025/12/22 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Levofloxacin Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20255409 | 2025/09/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Clindamycin Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20058213 | 2024/12/27 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Clindamycin Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20058212 | 2024/12/27 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Voriconazole for Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20249610 | 2024/12/01 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Peramivir Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20249216 | 2024/10/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metoprolol Tartrate Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20058056 | 2024/09/19 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Metoprolol Tartrate Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20058055 | 2024/09/19 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Doxofylline Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244561 | 2024/07/30 | Not stated by source | CDE ↗ |
| Ropivacaine hydrochloride injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244603 | 2024/07/30 | Not stated by source | CDE ↗ |
| Ropivacaine hydrochloride injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244605 | 2024/07/30 | Not stated by source | CDE ↗ |
| Ropivacaine hydrochloride injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244604 | 2024/07/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Doxofylline Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244562 | 2024/07/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ropivacaine hydrochloride injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20244602 | 2024/07/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Parecoxib Sodium for Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20243311 | 2024/03/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Parecoxib Sodium for Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20243312 | 2024/03/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Esmolol Hydrochloride Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20243036 | 2024/01/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ornidazole Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20234625 | 2023/12/13 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ornidazole Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20234626 | 2023/12/13 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Azithromycin For Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20234287 | 2023/10/12 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Argatroban Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20233692 | 2023/06/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ambroxol Hydrochloride Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20223444 | 2022/06/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Omeprazole Sodium for Injection | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | 国药准字H20067573 | 2021/06/04 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
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
3 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/13 06:41.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| 多索茶碱 · No verified English name | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Y20200000718 | A | 2023/03/24 | CDE ↗ |
| 甲磺酸罗哌卡因 · No verified English name | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Y20190004805 | A | 2025/10/31 | CDE ↗ |
| 卡络磺钠 · No verified English name | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | Y20190004795 | A | 2025/10/12 | CDE ↗ |
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
14 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 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Ambroxol Hydrochloride Oral Solution | CYHB2601505 | Supplement | 2026/08/25 | Shandong Lu Kang Hao Li You Bio Technology Kai Fa Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 醋酸地非法林注射液 · No verified English name | CYHS2602024 | Generic | 2026/08/17 | Shaanxi Ji Nuo Kang He Pharma Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Bromhexine Hydrochloride Injection | CYHS2404084 | Generic | 2024/11/28 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 盐酸二甲双胍缓释胶囊 · No verified English name | CYHB2401313 | Supplement | 2024/08/23 | Jilin Sheng Bai Nian Liu Fu Tang Pharma Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 诺氟沙星胶囊 · No verified English name | CYHB2401312 | Supplement | 2024/08/23 | Jilin Sheng Bai Nian Liu Fu Tang Pharma Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Sodium Bicarbonate Injection | CYHB2302679 | Supplement | 2023/12/07 | Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 吡哌酸片 · No verified English name | CYHB2302664 | Supplement | 2023/12/04 | Xizang Bang Chen Pharma Group Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 吡哌酸片 · No verified English name | CYHB2302663 | Supplement | 2023/12/04 | Xizang Bang Chen Pharma Group Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Diprophylline Injection | CYHS2302949 | Generic | 2023/10/31 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 注射用甘草酸二铵 · No verified English name | CYHB2301771 | Supplement | 2023/08/02 | Shaanxi Fu Dong Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 葛根素注射液 · No verified English name | CYHB2301567 | Supplement | 2023/07/13 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| Gabexate Mesilate For Injection | CYHB2301523 | Supplement | 2023/07/07 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 注射用硫酸长春新碱 · No verified English name | CYHB2300364 | Supplement | 2023/02/21 | Hainan Changchun Hua Pharma Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
| 三宝胶囊 · No verified English name | CYZB2100175 | Supplement | 2021/03/03 | Da Lian Tian Shan Pharma Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized | CDE ↗ |
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
- Full API register
- Last successful update: 2026/11/13 06:41
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 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.