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Gatifloxacin Eye Drops

As of 13 November 2026, for Gatifloxacin Eye Drops, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.

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

Listed in the US FDA Orange Book as ZYMAXID (NDA 022548, ABBVIE INC).

Last 90 days: Marketing application approved: 1 application

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 2 of 2 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
ZYMAXID ABBVIE INC NDA 022548 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2010/05/18
ZYMAR ALLERGAN INC NDA 021493 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 2003/03/28

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

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: 0 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
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 12 distinct approval numbers and 12 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Yao Ming Cheng De (Guangzhou) Pharmaceuticals Technology Co., Ltd. romanized国药准字H201200305ml:15mgCategory BXS01AEJ022G010010100389NHSA
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized国药准字H201101190.3%Category BXS01AEJ022G010010100967NHSA
Jiangsu Ji Bei Er Pharma Co., Ltd. romanized国药准字H200902360.3%Category BXS01AEJ022G010010101452NHSA
Jiangsu Yun Yang Group Pharma Co., Ltd. romanized国药准字H200600495ml:15mgCategory BXS01AEJ022G010010101519NHSA
Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized国药准字H201831580.3%(5ml:15mg)Category BXS01AEJ022G010010101955NHSA
Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized国药准字H200806530.3%Category BXS01AEJ022G010010103273NHSA
Hefei Li Fang Pharmaceutical Co., Ltd. romanized国药准字H200518250.3%(g/ml)Category BXS01AEJ022G010010104335NHSA
Hefei Li Min Pharmaceutical Co., Ltd. romanized国药准字H202631970.3%(5ml:15mg)Category BXS01AEJ022G010010104423NHSA
Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized国药准字H20060479See sourceCategory BXS01AEJ022G010010105593NHSA
Ningxia Kang Ya Pharma Co., Ltd. romanized国药准字H202032010.3%(5ml:15mg)Category BXS01AEJ022G010010105911NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202546110.3%(5ml:15mg)Category BXS01AEJ022G010010184019NHSA
Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized国药准字H202560850.3%(5ml:15mg)Category BXS01AEJ022G010010184751NHSA
Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized国药准字H201831580.3%(5ml:15mg)Category BXS01AEJ022G010010201955NHSA
Hefei Li Min Pharmaceutical Co., Ltd. romanized国药准字H202631970.3%(5ml:15mg)Category BXS01AEJ022G010010204423NHSA
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized国药准字H201101190.3%Category BXS01AEJ022G010020100967NHSA
Jiangsu Ji Bei Er Pharma Co., Ltd. romanized国药准字H200902360.3%Category BXS01AEJ022G010020101452NHSA
Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized国药准字H200806530.3%Category BXS01AEJ022G010020103273NHSA
Hefei Li Fang Pharmaceutical Co., Ltd. romanized国药准字H200518250.3%(g/ml)Category BXS01AEJ022G010020104335NHSA
Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized国药准字H20060479See sourceCategory BXS01AEJ022G010020105593NHSA
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized国药准字H201101190.3%Category BXS01AEJ022G010030100967NHSA
Hefei Li Fang Pharmaceutical Co., Ltd. romanized国药准字H200518250.3%(g/ml)Category BXS01AEJ022G010030104335NHSA
Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized国药准字H20060479See sourceCategory BXS01AEJ022G010030105593NHSA
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized国药准字H201101190.3%Category BXS01AEJ022G010040100967NHSA

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: 3 filings and 2 distinct first applicants.

Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2601932Generic2026/08/07Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2601710Generic2026/07/17Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2601709Generic2026/07/17Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2601932Generic2026/08/07Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2601710Generic2026/07/17Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2601709Generic2026/07/17Not stated by sourceCDE
API registrations

Non-component matches: 18 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
加替沙星 · No verified English nameDa Lian Yong Da Su Li Pharma Co., Ltd. romanizedY20250001032IExact ingredient2025/10/13CDE
加替沙星 · No verified English nameJiangsu Ji Bei Er Pharma Co., Ltd. romanizedY20240000024AExact ingredient2025/10/22CDE
加替沙星 · No verified English nameHefei Li Fang Pharmaceutical Co., Ltd. romanizedY20230000214AExact ingredient2024/12/20CDE
加替沙星 · No verified English nameNingxia Kang Ya Pharma Co., Ltd. romanizedY20220000678IExact ingredient2023/12/19CDE
加替沙星 · No verified English nameHubei Hua Dan Pharmaceuticals Technology Co., Ltd. romanizedY20190008909AExact ingredient2023/03/24CDE
加替沙星 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20190007219AExact ingredient2023/05/31CDE
盐酸加替沙星 · No verified English nameJiangsu Yong Da Pharma Co., Ltd. romanizedY20190007165ASalt-normalized ingredient—CDE
加替沙星 · No verified English nameYue Kang Pharma Group Anhui Tian Ran Pharmaceutical Co., Ltd. romanizedY20190006482AExact ingredient2026/03/19CDE
加替沙星 · No verified English nameJiangsu Yong Da Pharma Co., Ltd. romanizedY20190006468AExact ingredient—CDE
加替沙星 · No verified English nameXiu Zheng Pharma Group Liu He Pharmaceutical Co., Ltd. romanizedY20190006024AExact ingredient2025/03/29CDE
甲磺酸加替沙星 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190005424ASalt-normalized ingredient2024/06/12CDE
甲磺酸加替沙星 · No verified English nameJiangsu Ao Sai Kang Pharma Co., Ltd. romanizedY20190004764ASalt-normalized ingredient—CDE
加替沙星 · No verified English nameJiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190004678AExact ingredient—CDE
加替沙星 · No verified English nameSu Zhong Pharma Group Co., Ltd. romanizedY20190004063AExact ingredient2025/10/16CDE
加替沙星 · No verified English nameHubei Heng Di Pharma Co., Ltd. romanizedY20190003106AExact ingredient2025/06/06CDE
加替沙星 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20190002698AExact ingredient—CDE
盐酸加替沙星 · No verified English nameZhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanizedY20190002634ASalt-normalized ingredient2025/02/13CDE
加替沙星 · No verified English nameSichuan Bai Li Pharma Co., Ltd. romanizedY20190002633AExact ingredient2025/10/30CDE
加替沙星 · No verified English nameZhejiang Jian Feng Pharma Co., Ltd. romanizedY20190002485AExact ingredient—CDE
甲磺酸加替沙星 · No verified English nameHenan Kang Tai Pharma Co., Ltd. romanizedY20190001775ASalt-normalized ingredient2024/09/11CDE
乳酸加替沙星 · No verified English nameZhejiang Zhe Bang Pharmaceutical Co., Ltd. romanizedY20190001764ASalt-normalized ingredient—CDE

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. 2026/11/03Marketing application approved

    Hefei Nuo Rui Te Pharmaceutical Co., Ltd. romanized

    CYHS2501102 · 国药准字H20266445

    Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

    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 40 ↗

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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