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Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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 |
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.
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.
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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue 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.
Loaded records: 12 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Yao Ming Cheng De (Guangzhou) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20120030 | 5ml:15mg | Category B | XS01AEJ022G010010100389 | NHSA |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20110119 | 0.3% | Category B | XS01AEJ022G010010100967 | NHSA |
| Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | 国药准字H20090236 | 0.3% | Category B | XS01AEJ022G010010101452 | NHSA |
| Jiangsu Yun Yang Group Pharma Co., Ltd. romanized | 国药准字H20060049 | 5ml:15mg | Category B | XS01AEJ022G010010101519 | NHSA |
| Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 国药准字H20183158 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010101955 | NHSA |
| Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20080653 | 0.3% | Category B | XS01AEJ022G010010103273 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20051825 | 0.3%(g/ml) | Category B | XS01AEJ022G010010104335 | NHSA |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H20263197 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010104423 | NHSA |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479 | See source | Category B | XS01AEJ022G010010105593 | NHSA |
| Ningxia Kang Ya Pharma Co., Ltd. romanized | 国药准字H20203201 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010105911 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254611 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010184019 | NHSA |
| Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256085 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010184751 | NHSA |
| Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 国药准字H20183158 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010201955 | NHSA |
| Hefei Li Min Pharmaceutical Co., Ltd. romanized | 国药准字H20263197 | 0.3%(5ml:15mg) | Category B | XS01AEJ022G010010204423 | NHSA |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20110119 | 0.3% | Category B | XS01AEJ022G010020100967 | NHSA |
| Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | 国药准字H20090236 | 0.3% | Category B | XS01AEJ022G010020101452 | NHSA |
| Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20080653 | 0.3% | Category B | XS01AEJ022G010020103273 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20051825 | 0.3%(g/ml) | Category B | XS01AEJ022G010020104335 | NHSA |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479 | See source | Category B | XS01AEJ022G010020105593 | NHSA |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20110119 | 0.3% | Category B | XS01AEJ022G010030100967 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20051825 | 0.3%(g/ml) | Category B | XS01AEJ022G010030104335 | NHSA |
| Chu Xiong Lao Bo Yun Tang Pharma Co., Ltd. romanized | 国药准字H20060479 | See source | Category B | XS01AEJ022G010030105593 | NHSA |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20110119 | 0.3% | Category B | XS01AEJ022G010040100967 | NHSA |
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.
Loaded records: 3 filings and 2 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2601932 | Generic | 2026/08/07 | Not stated by source | CDE |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601710 | Generic | 2026/07/17 | Not stated by source | CDE |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601709 | Generic | 2026/07/17 | Not stated by source | CDE |
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2601932 | Generic | 2026/08/07 | Not stated by source | CDE |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601710 | Generic | 2026/07/17 | Not stated by source | CDE |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2601709 | Generic | 2026/07/17 | Not stated by source | CDE |
Non-component matches: 18 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 加替沙星 · No verified English name | Da Lian Yong Da Su Li Pharma Co., Ltd. romanized | Y20250001032 | I | Exact ingredient | 2025/10/13 | CDE |
| 加替沙星 · No verified English name | Jiangsu Ji Bei Er Pharma Co., Ltd. romanized | Y20240000024 | A | Exact ingredient | 2025/10/22 | CDE |
| 加替沙星 · No verified English name | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20230000214 | A | Exact ingredient | 2024/12/20 | CDE |
| 加替沙星 · No verified English name | Ningxia Kang Ya Pharma Co., Ltd. romanized | Y20220000678 | I | Exact ingredient | 2023/12/19 | CDE |
| 加替沙星 · No verified English name | Hubei Hua Dan Pharmaceuticals Technology Co., Ltd. romanized | Y20190008909 | A | Exact ingredient | 2023/03/24 | CDE |
| 加替沙星 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20190007219 | A | Exact ingredient | 2023/05/31 | CDE |
| 盐酸加替沙星 · No verified English name | Jiangsu Yong Da Pharma Co., Ltd. romanized | Y20190007165 | A | Salt-normalized ingredient | — | CDE |
| 加替沙星 · No verified English name | Yue Kang Pharma Group Anhui Tian Ran Pharmaceutical Co., Ltd. romanized | Y20190006482 | A | Exact ingredient | 2026/03/19 | CDE |
| 加替沙星 · No verified English name | Jiangsu Yong Da Pharma Co., Ltd. romanized | Y20190006468 | A | Exact ingredient | — | CDE |
| 加替沙星 · No verified English name | Xiu Zheng Pharma Group Liu He Pharmaceutical Co., Ltd. romanized | Y20190006024 | A | Exact ingredient | 2025/03/29 | CDE |
| 甲磺酸加替沙星 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190005424 | A | Salt-normalized ingredient | 2024/06/12 | CDE |
| 甲磺酸加替沙星 · No verified English name | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | Y20190004764 | A | Salt-normalized ingredient | — | CDE |
| 加替沙星 · No verified English name | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004678 | A | Exact ingredient | — | CDE |
| 加替沙星 · No verified English name | Su Zhong Pharma Group Co., Ltd. romanized | Y20190004063 | A | Exact ingredient | 2025/10/16 | CDE |
| 加替沙星 · No verified English name | Hubei Heng Di Pharma Co., Ltd. romanized | Y20190003106 | A | Exact ingredient | 2025/06/06 | CDE |
| 加替沙星 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002698 | A | Exact ingredient | — | CDE |
| 盐酸加替沙星 · No verified English name | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20190002634 | A | Salt-normalized ingredient | 2025/02/13 | CDE |
| 加替沙星 · No verified English name | Sichuan Bai Li Pharma Co., Ltd. romanized | Y20190002633 | A | Exact ingredient | 2025/10/30 | CDE |
| 加替沙星 · No verified English name | Zhejiang Jian Feng Pharma Co., Ltd. romanized | Y20190002485 | A | Exact ingredient | — | CDE |
| 甲磺酸加替沙星 · No verified English name | Henan Kang Tai Pharma Co., Ltd. romanized | Y20190001775 | A | Salt-normalized ingredient | 2024/09/11 | CDE |
| 乳酸加替沙星 · No verified English name | Zhejiang Zhe Bang Pharmaceutical Co., Ltd. romanized | Y20190001764 | A | Salt-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.
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.
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 ↗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.
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.
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.
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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