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Levetiracetam Oral Solution(左乙拉西坦口服溶液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
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 holders2View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers29View records ↓
API companies with A status28View records ↓
Chemical-drug catalogue
Loaded records: 2 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| — | 重庆圣华曦药业股份有限公司 | 国药准字H20183245 | 2018/07/06 | 150ml∶15g | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| UCB Pharma S.A. | NextPharma SAS | H20160152;H20160153 | 2011/03/04 | 10% | Imported originator drug (进口原研药品) | CDE |
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 26 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| UCB Pharma S.A. | 国药准字J20160060 | 10% | Category B (乙) | XN03AXZ075X001010100610 | NHSA |
| 上海美优制药有限公司 | 国药准字H20253954 | 150ml:15g | Category B (乙) | XN03AXZ075X001010100727 | NHSA |
| 健民集团叶开泰国药(随州)有限公司 | 国药准字H20203164 | 10%(150ml:15g) | Category B (乙) | XN03AXZ075X001010101945 | NHSA |
| 陕西天宇制药有限公司 | 国药准字H20253937 | 150ml:15g | Category B (乙) | XN03AXZ075X001010102433 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20234120 | 100ml:10g | Category B (乙) | XN03AXZ075X001010102753 | NHSA |
| 黑龙江珍宝岛药业股份有限公司 | 国药准字H20234346 | 150ml:15g | Category B (乙) | XN03AXZ075X001010103783 | NHSA |
| 长兴制药股份有限公司 | 国药准字H20244447 | 150ml:15g | Category B (乙) | XN03AXZ075X001010104465 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20213151 | 150ml:15g(10%) | Category B (乙) | XN03AXZ075X001010104649 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20193334 | 150ml:15g(10%) | Category B (乙) | XN03AXZ075X001010104658 | NHSA |
| 湖南嘉恒制药有限公司 | 国药准字H20243965 | 150ml:15g | Category B (乙) | XN03AXZ075X001010104891 | NHSA |
| 华润双鹤湘中药业(湖南)有限公司 | 国药准字H20253467 | 150ml:15g | Category B (乙) | XN03AXZ075X001010104971 | NHSA |
| 湖北多瑞药业有限公司 | 国药准字H20255490 | 150ml:15g | Category B (乙) | XN03AXZ075X001010106652 | NHSA |
| 海达舍画阁药业有限公司 | 国药准字H20213334 | 10%(150ml:15g) | Category B (乙) | XN03AXZ075X001010107913 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20183245 | 150ml∶15g | Category B (乙) | XN03AXZ075X001010109568 | NHSA |
| 河南华雒康润药业有限公司 | 国药准字H20233543 | 100ml:10g | Category B (乙) | XN03AXZ075X001010110323 | NHSA |
| 河北仁合益康药业有限公司 | 国药准字H20193176 | 150ml:15g | Category B (乙) | XN03AXZ075X001010110349 | NHSA |
| NextPharma SAS | H20160153 | 10% | Category B (乙) | XN03AXZ075X001010178930 | NHSA |
| Hetero Labs Limited | 国药准字HJ20240029 | 300ml:30g | Category B (乙) | XN03AXZ075X001010179426 | NHSA |
| 广东合威制药有限公司 | 国药准字H20265075 | 150ml:15g | Category B (乙) | XN03AXZ075X001010180447 | NHSA |
| 吉林四环澳康药业有限公司 | 国药准字H20255558 | 150ml:15g | Category B (乙) | XN03AXZ075X001010180760 | NHSA |
| 贵州阜康仁制药有限公司 | 国药准字H20244954 | 150ml: 15g | Category B (乙) | XN03AXZ075X001010183571 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20244796 | 150ml:15g | Category B (乙) | XN03AXZ075X001010183611 | NHSA |
| 北京亦嘉新创医疗器械技术研究院有限公司 | 国药准字H20244777 | 100ml:10g | Category B (乙) | XN03AXZ075X001010183695 | NHSA |
| 合肥淡滨尼药业有限公司 | 国药准字H20243832 | 150ml:15g | Category B (乙) | XN03AXZ075X001010184178 | NHSA |
| 江苏润恒制药有限公司 | 国药准字H20265792 | 150ml:15g | Category B (乙) | XN03AXZ075X001010185560 | NHSA |
| NextPharma SAS | 国药准字HJ20160153 | 10% | Category B (乙) | XN03AXZ075X001010278930 | NHSA |
| NextPharma SAS | 国药准字HJ20160152 | 10% | Category B (乙) | XN03AXZ075X001010378930 | NHSA |
| 神基(珠海)制药有限公司 | 国药准字H20247224 | 150ml: 15g | Category B (乙) | XN03AXZ075X001020100610 | NHSA |
| Hetero Labs Limited | 国药准字HJ20240028 | 150ml:15g | Category B (乙) | XN03AXZ075X001020179426 | 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: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 武汉人福药业有限责任公司 | CYHS2602577 | Generic | 2026/10/21 | Not stated by source | CDE |
| 翎耀生物科技（上海）有限公司;安徽新世纪药业有限公司 | CYHS2602072 | Generic | 2026/08/20 | Not stated by source | CDE |
| 岳阳新华达制药有限公司 | CYHS2501539 | Generic | 2025/04/24 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 28 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 左乙拉西坦 | 安徽悦康凯悦制药有限公司 | Y20230000273 | A | Exact ingredient | 2025/02/24 | CDE |
| 左乙拉西坦 | 浙江江北南海药业有限公司 | Y20230000609 | A | Exact ingredient | 2026/03/17 | CDE |
| 左乙拉西坦 | 吉林汇康制药有限公司 | Y20220000622 | A | Exact ingredient | 2024/05/30 | CDE |
| 左乙拉西坦 | EXEMED PHARMACEUTICALS | Y20210001275 | A | Exact ingredient | 2024/11/21 | CDE |
| 左乙拉西坦 | Chieron Active Ingredients Private Limited | Y20210000396 | A | Exact ingredient | 2025/10/27 | CDE |
| 左乙拉西坦 | Innovare Labs Private Limited | Y20200000851 | I | Exact ingredient | 2022/10/14 | CDE |
| 左乙拉西坦 | Srini Pharmaceuticals Private Limited | Y20200001057 | A | Exact ingredient | 2023/05/05 | CDE |
| 左乙拉西坦 | Lupin Limited | Y20200000807 | A | Exact ingredient | 2026/03/30 | CDE |
| 左乙拉西坦 | 兰西哈三联制药有限公司 | Y20200000517 | I | Exact ingredient | 2020/05/21 | CDE |
| 左乙拉西坦 | 潍坊市海欣药业有限公司 | Y20200000436 | A | Exact ingredient | 2022/10/28 | CDE |
| 左乙拉西坦 | 东北制药集团股份有限公司 | Y20200000328 | A | Exact ingredient | 2026/11/03 | CDE |
| 左乙拉西坦 | 吉林省博大制药股份有限公司 | Y20190000808 | A | Exact ingredient | 2026/07/13 | CDE |
| 左乙拉西坦 | 绍兴京新药业有限公司 | Y20190009888 | A | Exact ingredient | 2025/01/18 | CDE |
| 左乙拉西坦 | 重庆圣华曦药业股份有限公司 | Y20190007590 | A | Exact ingredient | 2024/07/24 | CDE |
| 左乙拉西坦 | 深圳信立泰药业股份有限公司 | Y20190007418 | A | Exact ingredient | 2023/10/11 | CDE |
| 左乙拉西坦 | 珠海联邦制药股份有限公司 | Y20190002685 | A | Exact ingredient | 2024/09/15 | CDE |
| 左乙拉西坦 | Hetero Labs Limited | Y20190000323 | A | Exact ingredient | 2026/03/31 | CDE |
| 左乙拉西坦 | DIVIS LABORATORIES LIMITED | Y20180001576 | A | Exact ingredient | 2024/03/14 | CDE |
| 左乙拉西坦 | 上虞京新药业有限公司 | Y20190000125 | A | Exact ingredient | 2024/11/14 | CDE |
| 左乙拉西坦 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20180001541 | A | Exact ingredient | 2025/09/04 | CDE |
| 左乙拉西坦 | 开封制药（集团）有限公司 | Y20180001524 | I | Exact ingredient | 2018/12/24 | CDE |
| 左乙拉西坦 | Neuland Laboratories Limited | Y20180000007 | A | Exact ingredient | 2026/05/20 | CDE |
| 左乙拉西坦 | 浙江江北药业有限公司 | Y20180001065 | A | Exact ingredient | 2025/11/11 | CDE |
| 左乙拉西坦 | 浙江新赛科药业有限公司 | Y20170002318 | A | Exact ingredient | 2024/05/28 | CDE |
| 左乙拉西坦 | Dr. Reddy’s Laboratories Limited | Y20180000334 | A | Exact ingredient | 2025/12/11 | CDE |
| 左乙拉西坦 | 廊坊高博京邦制药有限公司 | Y20170001734 | A | Exact ingredient | 2023/09/26 | CDE |
| 左乙拉西坦 | 浙江普洛家园药业有限公司 | Y20170001866 | A | Exact ingredient | 2024/08/10 | CDE |
| 左乙拉西坦 | 雅本化学股份有限公司 | Y20170001304 | A | Exact ingredient | 2023/10/20 | CDE |
| 左乙拉西坦 | Hetero Labs Limited | Y20170000999 | I | Exact ingredient | — | CDE |
| 左乙拉西坦 | 浙江华海药业股份有限公司 | Y20170000952 | A | Exact ingredient | 2026/05/20 | CDE |
| 左乙拉西坦 | 万特制药（海南）有限公司 | Y20170000700 | A | Exact ingredient | 2025/01/09 | CDE |
| 左乙拉西坦 | 河北创健药业有限公司 | Y20170000606 | A | Exact ingredient | 2024/04/03 | CDE |
| 左乙拉西坦 | 天方药业有限公司 | Y20170000302 | I | Exact 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/21Accepted
-
2026/08/20Accepted
翎耀生物科技（上海）有限公司;安徽新世纪药业有限公司
CYHS2602072
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗
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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