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Nimodipine Oral Solution

As of 13 November 2026, for Nimodipine Oral Solution, 4 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 NYMALIZE (NDA 203340, AZURITY PHARMACEUTICALS INC).

Last 90 days: No longer listed under review: 5 applicationsSupplement delivery: 1 application

Current coverage may be incomplete

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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 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: 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
NYMALIZE AZURITY PHARMACEUTICALS INC NDA 203340 · Product no. 002 SOLUTION ORAL HUMAN PRESCRIPTION DRUG 2020/04/08
NYMALIZE AZURITY PHARMACEUTICALS INC NDA 203340 · Product no. 001 SOLUTION ORAL DISCONTINUED 2013/05/10

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
NIMOTOP BAYER PHARMACEUTICALS CORP NDA 018869 · Product no. 001 CAPSULE ORAL DISCONTINUED 1988/12/28

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: 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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue 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: 11 distinct approval numbers and 10 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H2025493110ml:60mgNot stated by sourceXC08CAN043X001010101389NHSA
Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized国药准字H2022301420ml:60mgNot stated by sourceXC08CAN043X001010101445NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H2026617910ml:60mgNot stated by sourceXC08CAN043X001010102763NHSA
Zhejiang Guo Jing Pharma Co., Ltd. romanized国药准字H2023447610ml:60mgNot stated by sourceXC08CAN043X001010104634NHSA
Hainan Quan Xing Pharmaceutical Co., Ltd. romanized国药准字H20253866237ml:1.422gNot stated by sourceXC08CAN043X001010105765NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H2024428510ml:60mgNot stated by sourceXC08CAN043X001010181251NHSA
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized国药准字H2024391320ml:60mgNot stated by sourceXC08CAN043X001010181979NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H20244290237ml:1.422gNot stated by sourceXC08CAN043X001010182338NHSA
Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized国药准字H2025328910ml:60mgNot stated by sourceXC08CAN043X001010183339NHSA
Hunan Xian Shi Pharmaceutical Co., Ltd. romanized国药准字H2025400910ml:60mgNot stated by sourceXC08CAN043X001010184106NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H2024428510ml:60mgNot stated by sourceXC08CAN043X001010281251NHSA
Hunan Xian Shi Pharmaceutical Co., Ltd. romanized国药准字H2025400910ml:60mgNot stated by sourceXC08CAN043X001010284106NHSA
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized国药准字H2024428510ml:60mgNot stated by sourceXC08CAN043X001010381251NHSA
Hunan Xian Shi Pharmaceutical Co., Ltd. romanized国药准字H20254010237ml:1.422gNot stated by sourceXC08CAN043X001020184106NHSA

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 2 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanizedCYHS2600565Generic2026/02/27Not stated by sourceCDE
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanizedCYHS2600564Generic2026/02/27Not stated by sourceCDE
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanizedCYHS2600251Generic2026/01/22Not stated by sourceCDE
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanizedCYHS2600250Generic2026/01/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanizedCYHS2600565Generic2026/02/27Not stated by sourceCDE
Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanizedCYHS2600564Generic2026/02/27Not stated by sourceCDE
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanizedCYHS2600251Generic2026/01/22Not stated by sourceCDE
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanizedCYHS2600250Generic2026/01/22Not stated by sourceCDE
API registrations

Non-component matches: 11 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
尼莫地平 · No verified English nameUNION QUIMICO FARMACEUTICA, S.A.Y20250000153IExact ingredient2025/06/20CDE
尼莫地平 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20230001169AExact ingredient2026/11/08CDE
尼莫地平 · No verified English nameJiangsu Jiu Xu Pharma Co., Ltd. romanizedY20210000068AExact ingredient2025/10/11CDE
尼莫地平(预制颗粒) · No verified English nameBayer Vital GmbHY20200001505AExact ingredient2025/12/05CDE
尼莫地平 · No verified English nameSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDY20190009425AExact ingredient2025/02/13CDE
尼莫地平 · No verified English nameTianjin Shi Zhong Yang Pharma Co., Ltd. romanizedY20190008603AExact ingredient2025/06/28CDE
尼莫地平 · No verified English nameLe Sheng Pharma Shijiazhuang Co., Ltd. romanizedY20190005094AExact ingredient2024/12/10CDE
尼莫地平 · No verified English nameXian Bo Ai Pharmaceutical Co., Ltd. romanizedY20190004836AExact ingredient2025/07/28CDE
尼莫地平 · No verified English nameHenan Ke Lun Pharma Co., Ltd. romanizedY20190004746AExact ingredient2024/11/01CDE
尼莫地平 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20190004586AExact ingredient2026/03/31CDE
尼莫地平 · No verified English nameBeijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanizedY20190001823AExact ingredient2025/11/12CDE
尼莫地平 · No verified English nameZhengzhou Rui Kang Pharmaceutical Co., Ltd. romanizedY20190001753AExact ingredient2024/11/01CDE
尼莫地平(预制颗粒) · No verified English nameBayer Vital GmbHY20190000282IExact ingredient2019/08/12CDE
尼莫地平 · No verified English nameSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDY20180001435IExact ingredient2018/11/13CDE

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. 2026/11/10No longer listed under review

    Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHS2404433

    Fact date: 2026/11/10 · Site observation date: 2026/11/10

    Accepted: 2024/12/20

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/10No longer listed under review

    Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHS2404430

    Fact date: 2026/11/10 · Site observation date: 2026/11/10

    Accepted: 2024/12/20

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/11/10No longer listed under review

    Lian Huan Pharma (An Qing) Co., Ltd. romanized; Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHB2601545

    Fact date: 2026/11/10 · Site observation date: 2026/11/10

    Accepted: 2026/08/13

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  4. 2026/11/10No longer listed under review

    Lian Huan Pharma (An Qing) Co., Ltd. romanized; Jiangsu Lianhuan Pharmaceutical Co.,Ltd.

    CYHB2601544

    Fact date: 2026/11/10 · Site observation date: 2026/11/10

    Accepted: 2026/08/13

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  5. 2026/11/06No longer listed under review

    Zhejiang Guo Jing Pharma Co., Ltd. romanized

    CYHB2601489

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2026/08/04

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/04); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 22

    NMPA · Table row 22 ↗ View source ↗
  6. 2026/11/04Supplement delivery

    Zhejiang Guo Jing Pharma Co., Ltd. romanized

    CYHB2601489

    Fact date: 2026/11/04 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 22 ↗

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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