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Phenylephrine Hydrochloride Injection

As of 13 November 2026, for Phenylephrine Hydrochloride Injection, 5 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 22 holders.

Companies, stages and changes, with each record available on this page.

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

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.

Chemical-drug catalogue

Loaded records: 22 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 21 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanizedShandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202630442026/01/055ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanizedZhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized国药准字H202560872025/11/251ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Hai Yi Pharma Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202551872025/08/265ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202581642025/08/211ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Mankind Pharma LimitedMankind Pharma Limited国药准字HJ202500912025/07/291ml∶10mgGeneric approved under the new chemical-drug registration classificationCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanizedHUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H202548582025/07/155ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanizedHUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H202548572025/07/151ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Zhong Run Pharma Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202581182025/07/015ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
TC Pharmaceuticals (Jiangsu) Co., LtdTC Pharmaceuticals (Jiangsu) Co., Ltd国药准字H202544962025/06/101ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Anhui Heng Xing Pharmaceutical Co., Ltd. romanizedAnhui Heng Xing Pharmaceutical Co., Ltd. romanized国药准字H202544312025/06/035ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Anhui Chang Jiang Pharma Co., Ltd. romanizedAnhui Chang Jiang Pharma Co., Ltd. romanized国药准字H202541362025/05/131ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedHainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532462025/01/241ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedHainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532472025/01/2410ml:100mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Brilliant Pharmaceutical Co., Ltd.Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498402024/12/251ml∶10mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Brilliant Pharmaceutical Co., Ltd.Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498412024/12/255ml∶0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202497262024/12/101ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanizedShandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized国药准字H202497272024/12/105ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanizedJiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized国药准字H202492112024/10/291ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202492142024/10/291ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanizedNanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437232024/05/155ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanizedNanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437222024/05/151ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202436732024/05/081ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202436742024/05/085ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202435582024/04/245ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202435592024/04/241ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai He Feng Pharmaceutical Co., Ltd. romanizedShanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310211752023/08/101ml:10mgDrug that passed quality-and-efficacy consistency evaluationCDE
Zhong Run Pharma Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202333852023/03/241ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanizedHefei Yi Fan Biopharmaceutical Co., Ltd. romanized国药准字H202333872023/03/241ml:10mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202232862022/05/105ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanizedYunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202554692025/09/095ml︰0.5mgGeneric approved under the new chemical-drug registration classificationCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 29 distinct approval numbers and 21 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310211751ml:10mgCategory BXC01CAQ130B002010100673NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized国药准字H202544961ml:10mgCategory BXC01CAQ130B002010101751NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202232865ml:0.5mgCategory BXC01CAQ130B002010102181NHSA
Zhong Run Pharma Co., Ltd. romanized国药准字H202581185ml:0.5mgCategory BXC01CAQ130B002010102699NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202492141ml:10mgCategory BXC01CAQ130B002010102763NHSA
Anhui Chang Jiang Pharma Co., Ltd. romanized国药准字H202541361ml:10mgCategory BXC01CAQ130B002010104451NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498415ml∶0.5mgCategory BXC01CAQ130B002010105791NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532461ml:10mgCategory BXC01CAQ130B002010105801NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202554695ml:0.5mgCategory BXC01CAQ130B002010106286NHSA
Anhui Heng Xing Pharmaceutical Co., Ltd. romanized国药准字H202544315ml:0.5mgCategory BXC01CAQ130B002010107478NHSA
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized国药准字H202333871ml:10mgCategory BXC01CAQ130B002010182719NHSA
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H202492111ml:10mgCategory BXC01CAQ130B002010183035NHSA
Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized国药准字H202497275ml:0.5mgCategory BXC01CAQ130B002010183124NHSA
Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized国药准字H202497261ml:10mgCategory BXC01CAQ130B002010183237NHSA
Zhong Run Pharma Co., Ltd. romanized国药准字H202333851ml:10mgCategory BXC01CAQ130B002010183256NHSA
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H202435585ml:0.5mgCategory BXC01CAQ130B002010183337NHSA
Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized国药准字H202533881ml:10mgCategory BXC01CAQ130B002010183383NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437221ml∶10mgCategory BXC01CAQ130B002010183564NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H202436731ml:10mgCategory BXC01CAQ130B002010184534NHSA
Beijing Hai Yi Pharma Co., Ltd. romanized国药准字H202551875ml:0.5mgCategory BXC01CAQ130B002010185058NHSA
Zhuhai Qian Lie Pharma Co., Ltd. romanized国药准字H202548571ml:10mgCategory BXC01CAQ130B002010185087NHSA
Mankind Pharma Limited国药准字HJ202500911ml:10mgCategory BXC01CAQ130B002010185454NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310211751ml:10mgCategory BXC01CAQ130B002010200673NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized国药准字H202544961ml:10mgCategory BXC01CAQ130B002010201751NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202232865ml:0.5mgCategory BXC01CAQ130B002010202181NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202492141ml:10mgCategory BXC01CAQ130B002010202763NHSA
Anhui Chang Jiang Pharma Co., Ltd. romanized国药准字H202541361ml:10mgCategory BXC01CAQ130B002010204451NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498415ml∶0.5mgCategory BXC01CAQ130B002010205791NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532461ml:10mgCategory BXC01CAQ130B002010205801NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202554695ml:0.5mgCategory BXC01CAQ130B002010206286NHSA
Anhui Heng Xing Pharmaceutical Co., Ltd. romanized国药准字H202544315ml:0.5mgCategory BXC01CAQ130B002010207478NHSA
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized国药准字H202333871ml:10mgCategory BXC01CAQ130B002010282719NHSA
Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized国药准字H202492111ml:10mgCategory BXC01CAQ130B002010283035NHSA
Zhong Run Pharma Co., Ltd. romanized国药准字H202333851ml:10mgCategory BXC01CAQ130B002010283256NHSA
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H202435585ml:0.5mgCategory BXC01CAQ130B002010283337NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437221ml∶10mgCategory BXC01CAQ130B002010283564NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H202436731ml:10mgCategory BXC01CAQ130B002010284534NHSA
Mankind Pharma Limited国药准字HJ202500911ml:10mgCategory BXC01CAQ130B002010285454NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310211751ml:10mgCategory BXC01CAQ130B002010300673NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532461ml:10mgCategory BXC01CAQ130B002010305801NHSA
Zhong Run Pharma Co., Ltd. romanized国药准字H202333851ml:10mgCategory BXC01CAQ130B002010383256NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437221ml∶10mgCategory BXC01CAQ130B002010383564NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202532461ml:10mgCategory BXC01CAQ130B002010405801NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202581641ml:10mgCategory BXC01CAQ130B002020102181NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498401ml∶10mgCategory BXC01CAQ130B002020105791NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H2025324710ml:100mgCategory BXC01CAQ130B002020105801NHSA
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H202435591ml:10mgCategory BXC01CAQ130B002020183337NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437235ml:0.5mgCategory BXC01CAQ130B002020183564NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H202436745ml:0.5mgCategory BXC01CAQ130B002020184534NHSA
Zhuhai Qian Lie Pharma Co., Ltd. romanized国药准字H202548585ml:0.5mgCategory BXC01CAQ130B002020185087NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202581641ml:10mgCategory BXC01CAQ130B002020202181NHSA
Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized国药准字H202435591ml:10mgCategory BXC01CAQ130B002020283337NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437235ml:0.5mgCategory BXC01CAQ130B002020283564NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H202436745ml:0.5mgCategory BXC01CAQ130B002020284534NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202581641ml:10mgCategory BXC01CAQ130B002020302181NHSA
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized国药准字H202437235ml:0.5mgCategory BXC01CAQ130B002020383564NHSA
Hainan Brilliant Pharmaceutical Co., Ltd.国药准字H202498401ml∶10mgCategory BXC01CAQ130B002030105791NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 5 filings and 3 distinct first applicants.

Generic 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602101Generic2026/08/24Not stated by sourceCDE
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602100Generic2026/08/24Not stated by sourceCDE
Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanizedCYHS2600381Generic2026/02/05Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCYHS2600259Generic2026/01/23Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCYHS2600258Generic2026/01/23Not stated by sourceCDE
New generic filings in 2026

Loaded records: 5 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602101Generic2026/08/24Not stated by sourceCDE
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2602100Generic2026/08/24Not stated by sourceCDE
Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanizedCYHS2600381Generic2026/02/05Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCYHS2600259Generic2026/01/23Not stated by sourceCDE
Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCYHS2600258Generic2026/01/23Not stated by sourceCDE
API registrations

Non-component matches: 10 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸去氧肾上腺素 · No verified English nameHunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanizedY20260000025IExact ingredient2026/02/12CDE
盐酸去氧肾上腺素 · No verified English nameXu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedY20250000477IExact ingredient2025/05/22CDE
盐酸去氧肾上腺素 · No verified English nameWuhan Wu Yao Pharmaceutical Co., Ltd. romanizedY20240000593AExact ingredient2026/01/14CDE
盐酸去氧肾上腺素 · No verified English nameHubei Mei Lin Pharma Co., Ltd. romanizedY20240000416AExact ingredient2025/12/17CDE
盐酸去氧肾上腺素 · No verified English nameZhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanizedY20240000091AExact ingredient2025/11/22CDE
盐酸去氧肾上腺素 · No verified English nameAnhui Heng Xing Pharmaceutical Co., Ltd. romanizedY20230000387AExact ingredient2025/03/19CDE
盐酸去氧肾上腺素 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20220001108AExact ingredient2025/07/16CDE
盐酸去氧肾上腺素 · No verified English nameMalladi Drugs & Pharmaceuticals LimitedY20210000760AExact ingredient2025/01/15CDE
盐酸去氧肾上腺素 · No verified English nameShenzhen Wo Lan De Pharma Co., Ltd. romanizedY20190009335AExact ingredient2026/03/26CDE
盐酸去氧肾上腺素 · No verified English nameChi Feng Ai Ke Pharmaceutical Technology Co., Ltd. romanizedY20190004873AExact ingredient2024/10/10CDE
盐酸去氧肾上腺素 · No verified English nameZhejiang Hai Xiang Chuan Nan Pharma Co., Ltd. romanizedY20170001393AExact ingredient2024/04/10CDE
盐酸去氧肾上腺素 · No verified English nameDIVI'S LABORATORIES LTDY20170000948AExact ingredient2026/09/12CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/08/24Accepted

    Jiangsu Fu Bang Pharma Co., Ltd. romanized

    CYHS2602101

    Fact date: 2026/08/24 · Site observation date: 2026/10/21

    View source ↗
  2. 2026/08/24Accepted

    Jiangsu Fu Bang Pharma Co., Ltd. romanized

    CYHS2602100

    Fact date: 2026/08/24 · Site observation date: 2026/10/21

    View source ↗

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

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

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.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.

Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

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.

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