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Levetiracetam Oral Solution

As 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

Follow for free
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 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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

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: 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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Name not romanizedChongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H201832452018/07/06150ml∶15gGeneric approved under the new chemical-drug registration classificationCDE
UCB Pharma S.A.NextPharma SASH20160152;H201601532011/03/0410%Imported originator drugCDE

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 / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
UCB Pharma S.A.国药准字J2016006010%Category BXN03AXZ075X001010100610NHSA
Shanghai Mei You Pharmaceutical Co., Ltd. romanized国药准字H20253954150ml:15gCategory BXN03AXZ075X001010100727NHSA
Jian Min Group Ye Kai Tai Guo Yao (Sui Zhou) Co., Ltd. romanized国药准字H2020316410%(150ml:15g)Category BXN03AXZ075X001010101945NHSA
Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized国药准字H20253937150ml:15gCategory BXN03AXZ075X001010102433NHSA
Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized国药准字H20234120100ml:10gCategory BXN03AXZ075X001010102753NHSA
Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized国药准字H20234346150ml:15gCategory BXN03AXZ075X001010103783NHSA
Chang Xing Pharmaceutical Co., Ltd. romanized国药准字H20244447150ml:15gCategory BXN03AXZ075X001010104465NHSA
Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized国药准字H20213151150ml:15g(10%)Category BXN03AXZ075X001010104649NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H20193334150ml:15g(10%)Category BXN03AXZ075X001010104658NHSA
Hunan Jia Heng Pharmaceutical Co., Ltd. romanized国药准字H20243965150ml:15gCategory BXN03AXZ075X001010104891NHSA
Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized国药准字H20253467150ml:15gCategory BXN03AXZ075X001010104971NHSA
Hubei Duo Rui Pharma Co., Ltd. romanized国药准字H20255490150ml:15gCategory BXN03AXZ075X001010106652NHSA
Hai Da She Hua Ge Pharma Co., Ltd. romanized国药准字H2021333410%(150ml:15g)Category BXN03AXZ075X001010107913NHSA
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H20183245150ml∶15gCategory BXN03AXZ075X001010109568NHSA
Henan Hua Luo Kang Run Pharma Co., Ltd. romanized国药准字H20233543100ml:10gCategory BXN03AXZ075X001010110323NHSA
Hebei Ren He Yi Kang Pharma Co., Ltd. romanized国药准字H20193176150ml:15gCategory BXN03AXZ075X001010110349NHSA
NextPharma SASH2016015310%Category BXN03AXZ075X001010178930NHSA
Hetero Labs Limited国药准字HJ20240029300ml:30gCategory BXN03AXZ075X001010179426NHSA
Guangdong He Wei Pharmaceutical Co., Ltd. romanized国药准字H20265075150ml:15gCategory BXN03AXZ075X001010180447NHSA
Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized国药准字H20255558150ml:15gCategory BXN03AXZ075X001010180760NHSA
Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized国药准字H20244954150ml: 15gCategory BXN03AXZ075X001010183571NHSA
Jiangsu Guang Cheng Pharma Co., Ltd. romanized国药准字H20244796150ml:15gCategory BXN03AXZ075X001010183611NHSA
Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized国药准字H20244777100ml:10gCategory BXN03AXZ075X001010183695NHSA
Hefei Dan Bin Ni Pharma Co., Ltd. romanized国药准字H20243832150ml:15gCategory BXN03AXZ075X001010184178NHSA
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H20265792150ml:15gCategory BXN03AXZ075X001010185560NHSA
NextPharma SAS国药准字HJ2016015310%Category BXN03AXZ075X001010278930NHSA
NextPharma SAS国药准字HJ2016015210%Category BXN03AXZ075X001010378930NHSA
Shen Ji (Zhuhai) Pharmaceutical Co., Ltd. romanized国药准字H20247224150ml: 15gCategory BXN03AXZ075X001020100610NHSA
Hetero Labs Limited国药准字HJ20240028150ml:15gCategory BXN03AXZ075X001020179426NHSA

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

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602577Generic2026/10/21Not stated by sourceCDE
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanizedCYHS2602072Generic2026/08/20Not stated by sourceCDE
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanizedCYHS2501539Generic2025/04/24Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2602577Generic2026/10/21Not stated by sourceCDE
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanizedCYHS2602072Generic2026/08/20Not stated by sourceCDE
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.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
左乙拉西坦 · No verified English nameAnhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanizedY20230000273AExact ingredient2025/02/24CDE
左乙拉西坦 · No verified English nameZhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanizedY20230000609AExact ingredient2026/03/17CDE
左乙拉西坦 · No verified English nameJilin Hui Kang Pharmaceutical Co., Ltd. romanizedY20220000622AExact ingredient2024/05/30CDE
左乙拉西坦 · No verified English nameEXEMED PHARMACEUTICALSY20210001275AExact ingredient2024/11/21CDE
左乙拉西坦 · No verified English nameChieron Active Ingredients Private LimitedY20210000396AExact ingredient2025/10/27CDE
左乙拉西坦 · No verified English nameInnovare Labs Private LimitedY20200000851IExact ingredient2022/10/14CDE
左乙拉西坦 · No verified English nameSrini Pharmaceuticals Private LimitedY20200001057AExact ingredient2023/05/05CDE
左乙拉西坦 · No verified English nameLupin LimitedY20200000807AExact ingredient2026/03/30CDE
左乙拉西坦 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20200000517IExact ingredient2020/05/21CDE
左乙拉西坦 · No verified English nameWei Fang Shi Hai Xin Pharma Co., Ltd. romanizedY20200000436AExact ingredient2022/10/28CDE
左乙拉西坦 · No verified English nameDong Bei Pharmaceutical Group Co., Ltd. romanizedY20200000328AExact ingredient2026/11/03CDE
左乙拉西坦 · No verified English nameJilin Sheng Bo Da Pharmaceutical Co., Ltd. romanizedY20190000808AExact ingredient2026/07/13CDE
左乙拉西坦 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190009888AExact ingredient2025/01/18CDE
左乙拉西坦 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20190007590AExact ingredient2024/07/24CDE
左乙拉西坦 · No verified English nameShenzhen Xin Li Tai Pharma Co., Ltd. romanizedY20190007418AExact ingredient2023/10/11CDE
左乙拉西坦 · No verified English nameZhuhai Lian Bang Pharmaceutical Co., Ltd. romanizedY20190002685AExact ingredient2024/09/15CDE
左乙拉西坦 · No verified English nameHetero Labs LimitedY20190000323AExact ingredient2026/03/31CDE
左乙拉西坦 · No verified English nameDIVIS LABORATORIES LIMITEDY20180001576AExact ingredient2024/03/14CDE
左乙拉西坦 · No verified English nameShang Yu Jing Xin Pharma Co., Ltd. romanizedY20190000125AExact ingredient2024/11/14CDE
左乙拉西坦 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20180001541AExact ingredient2025/09/04CDE
左乙拉西坦 · No verified English nameKai Feng Pharmaceutical (Group) Co., Ltd. romanizedY20180001524IExact ingredient2018/12/24CDE
左乙拉西坦 · No verified English nameNeuland Laboratories LimitedY20180000007AExact ingredient2026/05/20CDE
左乙拉西坦 · No verified English nameZhejiang Jiang Bei Pharma Co., Ltd. romanizedY20180001065AExact ingredient2025/11/11CDE
左乙拉西坦 · No verified English nameZhejiang Xin Sai Ke Pharma Co., Ltd. romanizedY20170002318AExact ingredient2024/05/28CDE
左乙拉西坦 · No verified English nameDr. Reddy’s Laboratories LimitedY20180000334AExact ingredient2025/12/11CDE
左乙拉西坦 · No verified English nameLang Fang Gao Bo Jing Bang Pharmaceutical Co., Ltd. romanizedY20170001734AExact ingredient2023/09/26CDE
左乙拉西坦 · No verified English nameZhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanizedY20170001866AExact ingredient2024/08/10CDE
左乙拉西坦 · No verified English nameYa Ben Chemical Co., Ltd. romanizedY20170001304AExact ingredient2023/10/20CDE
左乙拉西坦 · No verified English nameHetero Labs LimitedY20170000999IExact ingredient—CDE
左乙拉西坦 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20170000952AExact ingredient2026/05/20CDE
左乙拉西坦 · No verified English nameWan Te Pharmaceutical (Hainan) Co., Ltd. romanizedY20170000700AExact ingredient2025/01/09CDE
左乙拉西坦 · No verified English nameHebei Chuang Jian Pharma Co., Ltd. romanizedY20170000606AExact ingredient2024/04/03CDE
左乙拉西坦 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20170000302IExact 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. 2026/10/21Accepted

    Wuhan Ren Fu Pharma Co., Ltd. romanized

    CYHS2602577

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/08/20Accepted

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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