YaoGeJu

Public drug landscapesDrug landscape

Sodium Nitroprusside Injection

As of 13 November 2026, for Sodium Nitroprusside Injection, 15 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 12 holders.

Companies, stages and changes, with each record available on this page.

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 3 of 3 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: Injection. 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
NIPRIDE HOFFMANN LA ROCHE INC NDA 017546 · Product no. 001 INJECTABLE INJECTION DISCONTINUED Approved prior to 1982 (exact date not listed)
NITROPRESS ABBVIE INC NDA 018450 · Product no. 001 INJECTABLE INJECTION DISCONTINUED Approved prior to 1982 (exact date not listed)

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
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% EXELA PHARMA SCIENCES LLC NDA 209387 · Product no. 001 SOLUTION INTRAVENOUS HUMAN PRESCRIPTION DRUG 2017/03/08
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% EXELA PHARMA SCIENCES LLC NDA 209387 · Product no. 003 SOLUTION INTRAVENOUS HUMAN PRESCRIPTION DRUG 2018/07/13
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% EXELA PHARMA SCIENCES LLC NDA 209387 · Product no. 002 SOLUTION INTRAVENOUS DISCONTINUED 2017/12/07

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: 12 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 12 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Dr. Reddy’s Laboratories LimitedDr. Reddy’s Laboratories Limited国药准字HJ202600862026/09/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Caplin Steriles LimitedCaplin Steriles Limited国药准字HJ202600852026/09/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Qidu Pharmaceutical Co., Ltd.Shandong Qidu Pharmaceutical Co., Ltd.国药准字H202658762026/09/08See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedBeijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H202655952026/08/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanizedKang Pu Pharma Co., Ltd. romanized国药准字H202649232026/06/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanizedHua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202643792026/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
YaoPharma Co., Ltd.YaoPharma Co., Ltd.国药准字H202641182026/04/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202634762026/02/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Xin Heng Chuang Pharma Co., Ltd. romanizedChengdu Xin Heng Chuang Pharma Co., Ltd. romanized国药准字H202492152024/10/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedHainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202232262022/04/12See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanizedHunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H202564052025/12/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Kang Pu Pharma Co., Ltd. romanizedKang Pu Pharma Co., Ltd. romanized国药准字H202662892026/10/20See sourceGeneric approved under the new chemical-drug registration classificationCDE

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: 10 distinct approval numbers and 10 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized国药准字H20265595See sourceCategory AXC02DDX070B002010100123NHSA
YaoPharma Co., Ltd.国药准字H20264118See sourceCategory AXC02DDX070B002010101066NHSA
Shandong Qidu Pharmaceutical Co., Ltd.国药准字H20265876See sourceCategory AXC02DDX070B002010104145NHSA
Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H20256405See sourceCategory AXC02DDX070B002010104900NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20223226See sourceCategory AXC02DDX070B002010105801NHSA
Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized国药准字H20249215See sourceCategory AXC02DDX070B002010109552NHSA
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H20264379See sourceCategory AXC02DDX070B002010109910NHSA
Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized国药准字H20264923See sourceCategory AXC02DDX070B002010183048NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263476See sourceCategory AXC02DDX070B002010184534NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263476See sourceCategory AXC02DDX070B002010284534NHSA
Caplin Steriles Limited国药准字HJ20260085See sourceCategory AXC02DDX070B002010185310NHSA

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: 15 filings and 14 distinct first applicants.

Generic 15

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2503804Generic2025/10/28Not stated by sourceCDE
Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCYHS2600947Generic2026/04/24Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2602475Generic2026/10/10Not stated by sourceCDE
Shanghai He Feng Pharmaceutical Co., Ltd. romanizedCYHS2503741Generic2025/10/21Not stated by sourceCDE
Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanizedCYHS2503444Generic2025/09/18Not stated by sourceCDE
Hua Run Shuang He Pharma Co., Ltd. romanizedCYHS2503066Generic2025/08/20Not stated by sourceCDE
Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanizedCYHS2502341Generic2025/07/02Not stated by sourceCDE
Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.CYHS2502228Generic2025/06/20Not stated by sourceCDE
Hainan Brilliant Pharmaceutical Co., Ltd.CYHS2502213Generic2025/06/20Not stated by sourceCDE
Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanizedCYHS2502175Generic2025/06/18Not stated by sourceCDE
Hebei Yi Pin Pharmaceutical Co., Ltd. romanizedCYHS2502011Generic2025/06/06Not stated by sourceCDE
Shandong Qidu Pharmaceutical Co., Ltd.CYHS2501982Generic2025/06/05Not stated by sourceCDE
Shandong Qidu Pharmaceutical Co., Ltd.CYHS2501981Generic2025/06/05Not stated by sourceCDE
Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS2501159Generic2025/03/25Not stated by sourceCDE
Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS2500578Generic2025/02/06Not 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
Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCYHS2600947Generic2026/04/24Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2602475Generic2026/10/10Not stated by sourceCDE
API registrations

Non-component matches: 17 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
硝普钠 · No verified English nameHunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY20260000486IExact ingredient2026/08/18CDE
硝普钠 · No verified English nameXu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedY20250001347IExact ingredient2025/12/15CDE
硝普钠 · No verified English nameHebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanizedY20250000236AExact ingredient2026/09/11CDE
硝普钠 · No verified English nameAnhui Pu Li Pharma Co., Ltd. romanizedY20240001218AExact ingredient2026/03/26CDE
硝普钠 · No verified English nameShandong Chuan Cheng Pharmaceuticals Co., Ltd. romanizedY20240000799AExact ingredient2026/10/31CDE
硝普钠 · No verified English nameShuang He Pharma (Shang Qiu) Co., Ltd. romanizedY20240000362AExact ingredient2025/08/22CDE
硝普钠 · No verified English nameHunan Heng Sheng Pharmaceutical Co., Ltd. romanizedY20240000094AExact ingredient2025/08/26CDE
硝普钠 · No verified English nameAzico Biophore India Pvt LtdY20230001195AExact ingredient2026/08/28CDE
硝普钠 · No verified English nameHenan Zhong Shuai Pharma Co., Ltd. romanizedY20220001337AExact ingredient2024/09/29CDE
硝普钠 · No verified English nameChengdu Xin Heng Chuang Pharma Co., Ltd. romanizedY20220001181AExact ingredient2025/12/20CDE
硝普钠 · No verified English nameHunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanizedY20210000083AExact ingredient2026/04/14CDE
硝普钠 · No verified English nameSan Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanizedY20190009710AExact ingredient2025/03/14CDE
硝普钠 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20190007504AExact ingredient2025/03/01CDE
硝普钠 · No verified English nameHua Run Shuang He Pharma Co., Ltd. romanizedY20190005092AExact ingredient2025/07/29CDE
硝普钠 · No verified English nameKang Pu Pharma Co., Ltd. romanizedY20190004573AExact ingredient2026/03/21CDE
硝普钠 · No verified English nameShanghai Di Ran Dan Cheng Pharmaceutical Co., Ltd. romanizedY20190004349AExact ingredient2024/11/01CDE
硝普钠 · No verified English nameBeijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedY20190003626AExact ingredient—CDE
硝普钠 · No verified English nameDan Dong Yi Chuang Pharma Co., Ltd. romanizedY20190002726AExact ingredient2025/05/22CDE
硝普钠 · No verified English nameHainan Pu Li Pharmaceutical Co., Ltd. romanizedY20190000020AExact ingredient2024/03/14CDE
硝普钠 · No verified English nameSan Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanizedY20170002000AExact ingredient2022/10/18CDE
硝普钠 · No verified English nameHebei Yi Pin Pharmaceutical Co., Ltd. romanizedY20260000897IExact ingredient2026/10/30CDE

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. 2026/11/03Marketing application approved

    Shanxi Jiu Kang Pharmaceuticals Technology Co., Ltd. romanized

    CYHS2501176 · 国药准字H20266490

    Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

    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 45 ↗
  2. 2026/10/31No longer listed under review

    Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized

    CYHS2501096

    Fact date: 2026/10/31 · Site observation date: 2026/10/31

    Accepted: 2025/03/18

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

    View source ↗
  3. 2026/10/31No longer listed under review

    Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized

    CYHS2501095

    Fact date: 2026/10/31 · Site observation date: 2026/10/31

    Accepted: 2025/03/18

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

    View source ↗
  4. 2026/10/20Marketing application approved

    Zhong Run Pharma Co., Ltd. romanized

    CYHS2501180 · 国药准字H20266312

    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 44 ↗
  5. 2026/10/20Marketing application approved

    Kang Pu Pharma Co., Ltd. romanized

    CYHS2500903 · 国药准字H20266289

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    Same-name approval records dated before this approval were found, with company roles identified below:

    • Manufacturer record / approval date · 国药准字H20264923 · 2026/06/23 · View source
    View source · Table row 39 ↗
  6. 2026/10/10Accepted

    Dan Dong Yi Chuang Pharma Co., Ltd. romanized

    CYHS2602475

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

    View source ↗

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.

Free follow

Follow changes to Sodium Nitroprusside Injection

Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.

Confirmation links expire in 7 days. No digest is sent before confirmation; existing follows are not duplicated.

Sign in to choose products