Monthly
US$200
Billed every month
Sign in to subscribeAs of 13 November 2026, for Levetiracetam Oral Solution, 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 2 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as KEPPRA (NDA 021505, UCB INC).
Last 90 days: Accepted: 2 applications
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 5 of 5 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: Oral Solution. 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 |
|---|---|---|---|---|---|---|
| KEPPRA | UCB INC | NDA 021505 · Product no. 001 | SOLUTION | ORAL | HUMAN PRESCRIPTION DRUG | 2003/07/15 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| KEPPRA | UCB INC | NDA 021035 · Product no. 001, 002, 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 1999/11/30 |
| KEPPRA | UCB INC | NDA 021035 · Product no. 004 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2006/01/06 |
| KEPPRA | UCB INC | NDA 021872 · Product no. 001 | INJECTABLE | INTRAVENOUS | HUMAN PRESCRIPTION DRUG | 2006/07/31 |
| KEPPRA XR | UCB INC | NDA 022285 · Product no. 001 | TABLET, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 2008/09/12 |
| KEPPRA XR | UCB INC | NDA 022285 · Product no. 002 | TABLET, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 2009/02/12 |
| LEVETIRACETAM IN SODIUM CHLORIDE | HQ SPECIALTY PHARMA CORP | NDA 202543 · Product no. 001, 002, 003 | INJECTABLE | INTRAVENOUS | HUMAN PRESCRIPTION DRUG | 2011/11/09 |
| SPRITAM | APRECIA PHARMACEUTICALS LLC | NDA 207958 · Product no. 001, 002 | TABLET, FOR SUSPENSION | ORAL | HUMAN PRESCRIPTION DRUG | 2015/07/31 |
| SPRITAM | APRECIA PHARMACEUTICALS LLC | NDA 207958 · Product no. 003, 004 | TABLET, FOR SUSPENSION | ORAL | DISCONTINUED | 2015/07/31 |
| ELEPSIA XR | TRIPOINT THERAPEUTICS | NDA 204417 · Product no. 001, 002 | TABLET, EXTENDED RELEASE | ORAL | DISCONTINUED | 2018/12/20 |
| LEVETIRACETAM IN SODIUM CHLORIDE | HQ SPECIALTY PHARMA CORP | NDA 202543 · Product no. 004 | INJECTABLE | INTRAVENOUS | DISCONTINUED | 2020/12/14 |
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: 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 |
|---|---|---|---|---|---|---|
| Name not romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20183245 | 2018/07/06 | 150ml∶15g | Generic approved under the new chemical-drug registration classification | CDE |
| UCB Pharma S.A. | NextPharma SAS | H20160152;H20160153 | 2011/03/04 | 10% | Imported originator drug | 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.
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 | XN03AXZ075X001010100610 | NHSA |
| Shanghai Mei You Pharmaceutical Co., Ltd. romanized | 国药准字H20253954 | 150ml:15g | Category B | XN03AXZ075X001010100727 | NHSA |
| Jian Min Group Ye Kai Tai Guo Yao (Sui Zhou) Co., Ltd. romanized | 国药准字H20203164 | 10%(150ml:15g) | Category B | XN03AXZ075X001010101945 | NHSA |
| Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20253937 | 150ml:15g | Category B | XN03AXZ075X001010102433 | NHSA |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234120 | 100ml:10g | Category B | XN03AXZ075X001010102753 | NHSA |
| Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized | 国药准字H20234346 | 150ml:15g | Category B | XN03AXZ075X001010103783 | NHSA |
| Chang Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20244447 | 150ml:15g | Category B | XN03AXZ075X001010104465 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213151 | 150ml:15g(10%) | Category B | XN03AXZ075X001010104649 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20193334 | 150ml:15g(10%) | Category B | XN03AXZ075X001010104658 | NHSA |
| Hunan Jia Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20243965 | 150ml:15g | Category B | XN03AXZ075X001010104891 | NHSA |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 国药准字H20253467 | 150ml:15g | Category B | XN03AXZ075X001010104971 | NHSA |
| Hubei Duo Rui Pharma Co., Ltd. romanized | 国药准字H20255490 | 150ml:15g | Category B | XN03AXZ075X001010106652 | NHSA |
| Hai Da She Hua Ge Pharma Co., Ltd. romanized | 国药准字H20213334 | 10%(150ml:15g) | Category B | XN03AXZ075X001010107913 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20183245 | 150ml∶15g | Category B | XN03AXZ075X001010109568 | NHSA |
| Henan Hua Luo Kang Run Pharma Co., Ltd. romanized | 国药准字H20233543 | 100ml:10g | Category B | XN03AXZ075X001010110323 | NHSA |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193176 | 150ml:15g | Category B | XN03AXZ075X001010110349 | NHSA |
| NextPharma SAS | H20160153 | 10% | Category B | XN03AXZ075X001010178930 | NHSA |
| Hetero Labs Limited | 国药准字HJ20240029 | 300ml:30g | Category B | XN03AXZ075X001010179426 | NHSA |
| Guangdong He Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20265075 | 150ml:15g | Category B | XN03AXZ075X001010180447 | NHSA |
| Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized | 国药准字H20255558 | 150ml:15g | Category B | XN03AXZ075X001010180760 | NHSA |
| Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized | 国药准字H20244954 | 150ml: 15g | Category B | XN03AXZ075X001010183571 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20244796 | 150ml:15g | Category B | XN03AXZ075X001010183611 | NHSA |
| Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized | 国药准字H20244777 | 100ml:10g | Category B | XN03AXZ075X001010183695 | NHSA |
| Hefei Dan Bin Ni Pharma Co., Ltd. romanized | 国药准字H20243832 | 150ml:15g | Category B | XN03AXZ075X001010184178 | NHSA |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20265792 | 150ml:15g | Category B | XN03AXZ075X001010185560 | NHSA |
| NextPharma SAS | 国药准字HJ20160153 | 10% | Category B | XN03AXZ075X001010278930 | NHSA |
| NextPharma SAS | 国药准字HJ20160152 | 10% | Category B | XN03AXZ075X001010378930 | NHSA |
| Shen Ji (Zhuhai) Pharmaceutical Co., Ltd. romanized | 国药准字H20247224 | 150ml: 15g | Category B | XN03AXZ075X001020100610 | NHSA |
| Hetero Labs Limited | 国药准字HJ20240028 | 150ml:15g | Category B | 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.
Loaded records: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602577 | Generic | 2026/10/21 | Not stated by source | CDE |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2602072 | Generic | 2026/08/20 | Not stated by source | CDE |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | CYHS2501539 | Generic | 2025/04/24 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602577 | Generic | 2026/10/21 | Not stated by source | CDE |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2602072 | Generic | 2026/08/20 | Not stated by source | CDE |
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 · No verified English name | Anhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanized | Y20230000273 | A | Exact ingredient | 2025/02/24 | CDE |
| 左乙拉西坦 · No verified English name | Zhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanized | Y20230000609 | A | Exact ingredient | 2026/03/17 | CDE |
| 左乙拉西坦 · No verified English name | Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20220000622 | A | Exact ingredient | 2024/05/30 | CDE |
| 左乙拉西坦 · No verified English name | EXEMED PHARMACEUTICALS | Y20210001275 | A | Exact ingredient | 2024/11/21 | CDE |
| 左乙拉西坦 · No verified English name | Chieron Active Ingredients Private Limited | Y20210000396 | A | Exact ingredient | 2025/10/27 | CDE |
| 左乙拉西坦 · No verified English name | Innovare Labs Private Limited | Y20200000851 | I | Exact ingredient | 2022/10/14 | CDE |
| 左乙拉西坦 · No verified English name | Srini Pharmaceuticals Private Limited | Y20200001057 | A | Exact ingredient | 2023/05/05 | CDE |
| 左乙拉西坦 · No verified English name | Lupin Limited | Y20200000807 | A | Exact ingredient | 2026/03/30 | CDE |
| 左乙拉西坦 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20200000517 | I | Exact ingredient | 2020/05/21 | CDE |
| 左乙拉西坦 · No verified English name | Wei Fang Shi Hai Xin Pharma Co., Ltd. romanized | Y20200000436 | A | Exact ingredient | 2022/10/28 | CDE |
| 左乙拉西坦 · No verified English name | Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20200000328 | A | Exact ingredient | 2026/11/03 | CDE |
| 左乙拉西坦 · No verified English name | Jilin Sheng Bo Da Pharmaceutical Co., Ltd. romanized | Y20190000808 | A | Exact ingredient | 2026/07/13 | CDE |
| 左乙拉西坦 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009888 | A | Exact ingredient | 2025/01/18 | CDE |
| 左乙拉西坦 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190007590 | A | Exact ingredient | 2024/07/24 | CDE |
| 左乙拉西坦 · No verified English name | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20190007418 | A | Exact ingredient | 2023/10/11 | CDE |
| 左乙拉西坦 · No verified English name | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190002685 | A | Exact ingredient | 2024/09/15 | CDE |
| 左乙拉西坦 · No verified English name | Hetero Labs Limited | Y20190000323 | A | Exact ingredient | 2026/03/31 | CDE |
| 左乙拉西坦 · No verified English name | DIVIS LABORATORIES LIMITED | Y20180001576 | A | Exact ingredient | 2024/03/14 | CDE |
| 左乙拉西坦 · No verified English name | Shang Yu Jing Xin Pharma Co., Ltd. romanized | Y20190000125 | A | Exact ingredient | 2024/11/14 | CDE |
| 左乙拉西坦 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20180001541 | A | Exact ingredient | 2025/09/04 | CDE |
| 左乙拉西坦 · No verified English name | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20180001524 | I | Exact ingredient | 2018/12/24 | CDE |
| 左乙拉西坦 · No verified English name | Neuland Laboratories Limited | Y20180000007 | A | Exact ingredient | 2026/05/20 | CDE |
| 左乙拉西坦 · No verified English name | Zhejiang Jiang Bei Pharma Co., Ltd. romanized | Y20180001065 | A | Exact ingredient | 2025/11/11 | CDE |
| 左乙拉西坦 · No verified English name | Zhejiang Xin Sai Ke Pharma Co., Ltd. romanized | Y20170002318 | A | Exact ingredient | 2024/05/28 | CDE |
| 左乙拉西坦 · No verified English name | Dr. Reddy’s Laboratories Limited | Y20180000334 | A | Exact ingredient | 2025/12/11 | CDE |
| 左乙拉西坦 · No verified English name | Lang Fang Gao Bo Jing Bang Pharmaceutical Co., Ltd. romanized | Y20170001734 | A | Exact ingredient | 2023/09/26 | CDE |
| 左乙拉西坦 · No verified English name | Zhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanized | Y20170001866 | A | Exact ingredient | 2024/08/10 | CDE |
| 左乙拉西坦 · No verified English name | Ya Ben Chemical Co., Ltd. romanized | Y20170001304 | A | Exact ingredient | 2023/10/20 | CDE |
| 左乙拉西坦 · No verified English name | Hetero Labs Limited | Y20170000999 | I | Exact ingredient | — | CDE |
| 左乙拉西坦 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20170000952 | A | Exact ingredient | 2026/05/20 | CDE |
| 左乙拉西坦 · No verified English name | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20170000700 | A | Exact ingredient | 2025/01/09 | CDE |
| 左乙拉西坦 · No verified English name | Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20170000606 | A | Exact ingredient | 2024/04/03 | CDE |
| 左乙拉西坦 · No verified English name | Topfond Pharmaceutical Co., Ltd. | 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.
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.
CYHS2602577
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗CYHS2602072
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗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.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
Sign in to subscribeUS$540
Billed every three months
US$180 per month
Sign in to subscribeUS$1,920
Billed every year
US$160 per month
Sign in to subscribeSeparate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy