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氧氟沙星滴耳液
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders0View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers19View records ↓
API companies with A status13View records ↓
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 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.
NHSA drug codes
Loaded records: 19 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 上海小方制药股份有限公司 | 国药准字H10950207 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010100830 | NHSA |
| 上海信谊金朱药业有限公司 | 国药准字H20067440 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010100840 | NHSA |
| 济川药业集团有限公司 | 国药准字H10950246 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010101453 | NHSA |
| 南京天朗制药有限公司 | 国药准字H20094236 | 0.3% | Category A (甲) | XS02AAY040Q010010101589 | NHSA |
| 湖北潜江制药股份有限公司 | 国药准字H42022294 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010101840 | NHSA |
| 宜昌诺安制药有限公司 | 国药准字H20083321 | 0.3%(5ml:15mg,8ml:24mg,10ml:30mg) | Category A (甲) | XS02AAY040Q010010101955 | NHSA |
| 武汉五景药业有限公司 | 国药准字H20083329 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010101978 | NHSA |
| 山东光明药业有限公司 | 国药准字H20249487 | 0.3%(5ml:15mg) | Category A (甲) | XS02AAY040Q010010102562 | NHSA |
| 开封制药(集团)有限公司 | 国药准字H10950095 | 8ml:24mg | Category A (甲) | XS02AAY040Q010010103008 | NHSA |
| 郑州卓峰制药有限公司 | 国药准字H41021439 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010103273 | NHSA |
| 黑龙江龙桂制药有限公司 | 国药准字H20074127 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010103750 | NHSA |
| 山东博士伦福瑞达制药有限公司 | 国药准字H20063471 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010104072 | NHSA |
| 山东辰欣佛都药业股份有限公司 | 国药准字H20055980 | (1)5ml:15mg(2)8ml:24mg | Category A (甲) | XS02AAY040Q010010104127 | NHSA |
| 威海华新药业集团有限公司 | 国药准字H10950227 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010104217 | NHSA |
| 安徽环球药业股份有限公司 | 国药准字H10950139 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010104303 | NHSA |
| 合肥利民制药有限公司 | 国药准字H20265119 | 0.3%(5ml:15mg) | Category A (甲) | XS02AAY040Q010010104423 | NHSA |
| 浙江尖峰药业有限公司 | 国药准字H10950049 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010104655 | NHSA |
| 海南诚锐生物科技有限公司 | 国药准字H20244259 | 0.3%(5ml:15mg) | Category A (甲) | XS02AAY040Q010010183945 | NHSA |
| 江苏宝东医药科技有限公司 | 国药准字H20264423 | 0.3%(5ml:15mg) | Category A (甲) | XS02AAY040Q010010185524 | NHSA |
| 南京天朗制药有限公司 | 国药准字H20094236 | 0.3% | Category A (甲) | XS02AAY040Q010010201589 | NHSA |
| 湖北潜江制药股份有限公司 | 国药准字H42022294 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010201840 | NHSA |
| 山东辰欣佛都药业股份有限公司 | 国药准字H20055980 | (1)5ml:15mg(2)8ml:24mg | Category A (甲) | XS02AAY040Q010010204127 | NHSA |
| 安徽环球药业股份有限公司 | 国药准字H10950139 | 5ml:15mg | Category A (甲) | XS02AAY040Q010010204303 | NHSA |
| 江苏宝东医药科技有限公司 | 国药准字H20264423 | 0.3%(5ml:15mg) | Category A (甲) | XS02AAY040Q010010285524 | NHSA |
| 上海小方制药股份有限公司 | 国药准字H10950207 | 5ml:15mg | Category A (甲) | XS02AAY040Q010020100830 | NHSA |
| 南京天朗制药有限公司 | 国药准字H20094236 | 0.3% | Category A (甲) | XS02AAY040Q010020101589 | NHSA |
| 宜昌诺安制药有限公司 | 国药准字H20083321 | 0.3%(5ml:15mg,8ml:24mg,10ml:30mg) | Category A (甲) | XS02AAY040Q010020101955 | NHSA |
| 黑龙江龙桂制药有限公司 | 国药准字H20074127 | 5ml:15mg | Category A (甲) | XS02AAY040Q010020103750 | NHSA |
| 山东辰欣佛都药业股份有限公司 | 国药准字H20055980 | (1)5ml:15mg(2)8ml:24mg | Category A (甲) | XS02AAY040Q010020104127 | NHSA |
| 山东辰欣佛都药业股份有限公司 | 国药准字H20055980 | (1)5ml:15mg(2)8ml:24mg | Category A (甲) | XS02AAY040Q010020204127 | NHSA |
| 南京天朗制药有限公司 | 国药准字H20094236 | 0.3% | Category A (甲) | XS02AAY040Q010030101589 | NHSA |
| 宜昌诺安制药有限公司 | 国药准字H20083321 | 0.3%(5ml:15mg,8ml:24mg,10ml:30mg) | Category A (甲) | XS02AAY040Q010030101955 | NHSA |
| 黑龙江龙桂制药有限公司 | 国药准字H20074127 | 5ml:15mg | Category A (甲) | XS02AAY040Q010030203750 | NHSA |
| 南京天朗制药有限公司 | 国药准字H20094236 | 0.3% | Category A (甲) | XS02AAY040Q010040101589 | NHSA |
| 黑龙江龙桂制药有限公司 | 国药准字H20074127 | 5ml:15mg | Category A (甲) | XS02AAY040Q010040103750 | 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.
Current under-review applications
Loaded records: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏远恒药业有限公司 | CYHS2602207 | Generic | 2026/09/04 | Not stated by source | CDE |
| 南京帝昌医药科技有限公司;安徽环球药业股份有限公司 | CYHS2600826 | Generic | 2026/04/10 | Not stated by source | CDE |
| 宁夏康亚药业股份有限公司 | CYHS2503735 | Generic | 2025/10/18 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2502122 | Generic | 2025/06/14 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 13 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 氧氟沙星 | 石家庄格瑞药业有限公司 | Y20250000805 | I | Exact ingredient | 2025/09/08 | CDE |
| 氧氟沙星 | 浙江东亚药业股份有限公司 | Y20190009341 | A | Exact ingredient | 2025/04/24 | CDE |
| 氧氟沙星 | DAIICHI SANKYO CO., LTD. | Y20190009142 | A | Exact ingredient | 2024/10/29 | CDE |
| 氧氟沙星 | 天方药业有限公司 | Y20190007438 | A | Exact ingredient | 2024/11/01 | CDE |
| 氧氟沙星 | 好医生药业集团有限公司 | Y20190005984 | A | Exact ingredient | — | CDE |
| 氧氟沙星 | 浙江朗华制药有限公司 | Y20190005601 | A | Exact ingredient | 2024/10/16 | CDE |
| 氧氟沙星 | 重庆西南合成制药有限公司 | Y20190005289 | A | Exact ingredient | — | CDE |
| 氧氟沙星 | 山西榆化精细化工有限公司 | Y20190005215 | A | Exact ingredient | 2025/06/28 | CDE |
| 氧氟沙星 | 华润双鹤药业股份有限公司 | Y20190004571 | A | Exact ingredient | — | CDE |
| 氧氟沙星 | 东港市宏达制药有限公司 | Y20190004160 | A | Exact ingredient | 2025/04/15 | CDE |
| 氧氟沙星 | 浙江永宁药业股份有限公司 | Y20190003476 | A | Exact ingredient | 2024/12/07 | CDE |
| 氧氟沙星 | 浙江普洛康裕制药有限公司 | Y20190002494 | A | Exact ingredient | 2024/12/10 | CDE |
| 氧氟沙星 | 浙江医药股份有限公司新昌制药厂 | Y20190002488 | A | Exact ingredient | 2025/02/13 | CDE |
| 氧氟沙星 | 绍兴京新药业有限公司 | Y20190002235 | A | Exact ingredient | 2024/06/12 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/20Marketing application approved
石家庄格瑞药业有限公司
CYHS2503024 · 国药准字H20266346
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 98 ↗ -
2026/09/04Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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: 2026/11/10 07:25
- 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: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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