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Olopatadine Hydrochloride Eye Drops

As of 13 November 2026, for Olopatadine Hydrochloride Eye Drops, 13 applications are listed as under review at China's CDE; 6 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

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

Listed in the US FDA Orange Book as PATADAY TWICE DAILY RELIEF (NDA 020688, ALCON LABORATORIES INC).

Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications

Current coverage may be incomplete

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

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 3 of 3 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Eye Drops. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
PATADAY TWICE DAILY RELIEF ALCON LABORATORIES INC NDA 020688 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN OTC DRUG 1996/12/18
PATADAY ONCE DAILY RELIEF ALCON LABORATORIES INC NDA 021545 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN OTC DRUG 2004/12/22
PATADAY ONCE DAILY RELIEF ALCON LABORATORIES INC NDA 206276 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN OTC DRUG 2015/01/30

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
PATANASE NOVARTIS PHARMACEUTICALS CORP NDA 021861 · Product no. 001 SPRAY, METERED NASAL DISCONTINUED 2008/04/15

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Novartis Europharm LimitedS.A.Alcon Couvreur N.V.H201811462002/06/13See sourceImported originator drugCDE

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: 43 distinct approval numbers and 34 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangdong Nan Guo Pharma Co., Ltd. romanized国药准字H20265833See sourceCategory BXS01GXA210G010010100315NHSA
Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized国药准字H20254147See sourceCategory BXS01GXA210G010010100483NHSA
Shenzhen Wan He Pharmaceutical Co., Ltd. romanized国药准字H20253371See sourceCategory BXS01GXA210G010010100547NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20193101See sourceCategory BXS01GXA210G010010101322NHSA
Jiangsu Fu Bang Pharma Co., Ltd. romanized国药准字H20255814See sourceCategory BXS01GXA210G010010101438NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010010101442NHSA
Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized国药准字H20243121See sourceCategory BXS01GXA210G010010101652NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249048See sourceCategory BXS01GXA210G010010101967NHSA
Wuhan Wu Jing Pharma Co., Ltd. romanized国药准字H20264530See sourceCategory BXS01GXA210G010010101978NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H20244478See sourceCategory BXS01GXA210G010010102087NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20234561See sourceCategory BXS01GXA210G010010102298NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H200838260.1%Category BXS01GXA210G010010102680NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010102733NHSA
Changchun Di Rui Pharmaceutical Co., Ltd. romanized国药准字H20263810See sourceCategory BXS01GXA210G010010103305NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H20183099See sourceCategory BXS01GXA210G010010104021NHSA
Hefei Hua Wei Pharma Co., Ltd. romanized国药准字H20233973See sourceCategory BXS01GXA210G010010104388NHSA
Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized国药准字H20243943See sourceCategory BXS01GXA210G010010104454NHSA
Zhejiang Jian Feng Pharma Co., Ltd. romanized国药准字H20193095See sourceCategory BXS01GXA210G010010104655NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H20253402See sourceCategory BXS01GXA210G010010104693NHSA
Jiangxi Ma Ying Long Mei Kang Pharma Co., Ltd. romanized国药准字H20255181See sourceCategory BXS01GXA210G010010105293NHSA
Jiangxi Ke Lun Pharma Co., Ltd. romanized国药准字H20183402See sourceCategory BXS01GXA210G010010105319NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010010105816NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20234503See sourceCategory BXS01GXA210G010010105847NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20173398See sourceCategory BXS01GXA210G010010107415NHSA
Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized国药准字H20183436See sourceCategory BXS01GXA210G010010109591NHSA
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized国药准字H20203419See sourceCategory BXS01GXA210G010010109909NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H20265956See sourceCategory BXS01GXA210G010010110144NHSA
Hebei Chuang Jian Pharma Co., Ltd. romanized国药准字H20234645See sourceCategory BXS01GXA210G010010110364NHSA
Novartis Europharm Limited国药准字HJ20181146See sourceCategory BXS01GXA210G010010178195NHSA
Novartis pharmaceuticals Corporation国药准字HJ20200062See sourceCategory BXS01GXA210G010010179584NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H20243440See sourceCategory BXS01GXA210G010010183035NHSA
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized国药准字H20258231See sourceCategory BXS01GXA210G010010183060NHSA
Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized国药准字H20233505See sourceCategory BXS01GXA210G010010183124NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20256442See sourceCategory BXS01GXA210G010010183549NHSA
Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized国药准字H20243749See sourceCategory BXS01GXA210G010010184070NHSA
Ai Shi Pharmaceutical Co., Ltd. romanized国药准字H20249046See sourceCategory BXS01GXA210G010010184160NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249048See sourceCategory BXS01GXA210G010010201967NHSA
Wuhan Wu Jing Pharma Co., Ltd. romanized国药准字H20264530See sourceCategory BXS01GXA210G010010201978NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20234561See sourceCategory BXS01GXA210G010010202298NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010202733NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010010205816NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H20243440See sourceCategory BXS01GXA210G010010283035NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249048See sourceCategory BXS01GXA210G010010301967NHSA
Wuhan Wu Jing Pharma Co., Ltd. romanized国药准字H20264530See sourceCategory BXS01GXA210G010010301978NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20234561See sourceCategory BXS01GXA210G010010302298NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010302733NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010010305816NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H20243440See sourceCategory BXS01GXA210G010010383035NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249048See sourceCategory BXS01GXA210G010010401967NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20234561See sourceCategory BXS01GXA210G010010402298NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010402733NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010010405816NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H20249048See sourceCategory BXS01GXA210G010010501967NHSA
Chengdu Pusch Pharmaceutical Co., Ltd.国药准字H20234561See sourceCategory BXS01GXA210G010010502298NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010502733NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010010505816NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249754See sourceCategory BXS01GXA210G010010602733NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H20249276See sourceCategory BXS01GXA210G010020101322NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010020101442NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020102733NHSA
Changchun Di Rui Pharmaceutical Co., Ltd. romanized国药准字H20263809See sourceCategory BXS01GXA210G010020103305NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H20204033See sourceCategory BXS01GXA210G010020104021NHSA
Zhejiang Jian Feng Pharma Co., Ltd. romanized国药准字H20247155See sourceCategory BXS01GXA210G010020104655NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H20233103See sourceCategory BXS01GXA210G010020105816NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20173398See sourceCategory BXS01GXA210G010020107415NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H20243440See sourceCategory BXS01GXA210G010020183035NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020202733NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020302733NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020402733NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020502733NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20249755See sourceCategory BXS01GXA210G010020602733NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010030101442NHSA
Shijiazhuang Gree Pharmaceutical Co., Ltd国药准字H20254150See sourceCategory BXS01GXA210G010030102733NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H20204033See sourceCategory BXS01GXA210G010030104021NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20173398See sourceCategory BXS01GXA210G010030107415NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H20233951See sourceCategory BXS01GXA210G010030183035NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010040101442NHSA
Guangdong Hong Ying Technology Co., Ltd. romanized国药准字H20173398See sourceCategory BXS01GXA210G010040107415NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010050101442NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20183349See sourceCategory BXS01GXA210G010060101442NHSA

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: 13 filings and 13 distinct first applicants.

Generic 10 · Supplement 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2601339Generic2026/06/08Not stated by sourceCDE
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHB2502477Supplement2025/12/05Not stated by sourceCDE
Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanizedCYHS2602464Generic2026/10/09Not stated by sourceCDE
Zhen Shi Ming (Jiangxi) Pharma Co., Ltd. romanizedCYHS2602205Generic2026/09/04Not stated by sourceCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS2601145Generic2026/05/14Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHB2600909Supplement2026/05/13Not stated by sourceCDE
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanizedCYHS2600880Generic2026/04/17Not stated by sourceCDE
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanizedCYHS2600474Generic2026/02/13Not stated by sourceCDE
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanizedCYHS2504403Generic2025/12/25Not stated by sourceCDE
Novartis Europharm Limited; Novartis Manufacturing NVJYHB2500521Supplement2025/10/14Not stated by sourceCDE
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2503239Generic2025/09/03Not stated by sourceCDE
Sichuan He Yi Pharmaceutical Co., Ltd. romanizedCYHS2502362Generic2025/07/04Not stated by sourceCDE
Guangzhou Wei Ao Kang Pharma Technology Co., Ltd. romanized; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanizedCYHS2501637Generic2025/05/01Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 6 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2601339Generic2026/06/08Not stated by sourceCDE
Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanizedCYHS2602464Generic2026/10/09Not stated by sourceCDE
Zhen Shi Ming (Jiangxi) Pharma Co., Ltd. romanizedCYHS2602205Generic2026/09/04Not stated by sourceCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS2601145Generic2026/05/14Not stated by sourceCDE
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanizedCYHS2600880Generic2026/04/17Not stated by sourceCDE
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanizedCYHS2600474Generic2026/02/13Not stated by sourceCDE
API registrations

Non-component matches: 16 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸奥洛他定 · No verified English namePrecise Biopharma Pvt LtdY20240001453IExact ingredient2025/10/16CDE
盐酸奥洛他定 · No verified English nameShijiazhuang Gree Pharmaceutical Co., LtdY20230000466AExact ingredient2025/09/29CDE
盐酸奥洛他定 · No verified English nameXin Xiang Hai Bin Pharma Co., Ltd. romanizedY20220001158AExact ingredient2024/06/21CDE
盐酸奥洛他定 · No verified English nameJiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedY20200001291AExact ingredient2023/01/04CDE
盐酸奥洛他定 · No verified English nameSichuan Zi Ren Pharmaceutical Co., Ltd. romanizedY20200000735AExact ingredient2022/10/28CDE
盐酸奥洛他定 · No verified English nameHebei Chuang Jian Pharma Co., Ltd. romanizedY20200000675AExact ingredient2024/02/21CDE
盐酸奥洛他定 · No verified English nameCURIA SPAIN S.A.U.Y20190009103AExact ingredient2026/10/14CDE
盐酸奥洛他定 · No verified English nameCRYSTAL PHARMA S.A.U.Y20190009102AExact ingredient—CDE
盐酸奥洛他定 · No verified English nameKyowa Hakko Kirin Co.,Ltd.Y20190009080AExact ingredient—CDE
盐酸奥洛他定 · No verified English nameChongqing Xi Nan Pharmaceutical Er Factory Co., Ltd. romanizedY20190008886AExact ingredient—CDE
盐酸奥洛他定 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20190008405AExact ingredient2024/08/29CDE
盐酸奥洛他定 · No verified English nameWu Yi Ci Hang Pharma Co., Ltd. romanizedY20190007169AExact ingredient2023/03/24CDE
盐酸奥洛他定 · No verified English nameQilu Pharmaceutical Co., Ltd.Y20190006800AExact ingredient—CDE
盐酸奥洛他定 · No verified English nameJin Cheng Hai Si Pharmaceutical Co., Ltd. romanizedY20170001002AExact ingredient2023/05/16CDE
盐酸奥洛他定 · No verified English namePCAS Finland OyY20170000692AExact ingredient2024/10/29CDE
盐酸奥洛他定 · No verified English nameMSN Laboratories Private LimitedY20170000299AExact ingredient2024/12/31CDE
盐酸奥洛他定 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20170000273AExact ingredient2025/04/22CDE

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. 2026/10/20Marketing application approved

    Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized

    CYHS2502787 · 国药准字H20266329

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.

    View source · Table row 96 ↗
  2. 2026/10/09Accepted
  3. 2026/09/04Accepted

    Zhen Shi Ming (Jiangxi) Pharma Co., Ltd. romanized

    CYHS2602205

    Fact date: 2026/09/04 · Site observation date: 2026/10/22

    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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