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Sign in to subscribeAs 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.
Last 90 days: Marketing application approved: 3 applicationsAccepted: 1 applicationNo longer listed under review: 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 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.
| Brand name | Applicant (source text) | Application number | Dosage 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) |
| Brand name | Applicant (source text) | Application number | Dosage 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.
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: 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Dr. Reddy’s Laboratories Limited | Dr. Reddy’s Laboratories Limited | 国药准字HJ20260086 | 2026/09/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Caplin Steriles Limited | Caplin Steriles Limited | 国药准字HJ20260085 | 2026/09/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20265876 | 2026/09/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20265595 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | Kang Pu Pharma Co., Ltd. romanized | 国药准字H20264923 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20264379 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| YaoPharma Co., Ltd. | YaoPharma Co., Ltd. | 国药准字H20264118 | 2026/04/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20263476 | 2026/02/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | 国药准字H20249215 | 2024/10/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20223226 | 2022/04/12 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256405 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Kang Pu Pharma Co., Ltd. romanized | Kang Pu Pharma Co., Ltd. romanized | 国药准字H20266289 | 2026/10/20 | See source | Generic approved under the new chemical-drug registration classification | 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: 10 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20265595 | See source | Category A | XC02DDX070B002010100123 | NHSA |
| YaoPharma Co., Ltd. | 国药准字H20264118 | See source | Category A | XC02DDX070B002010101066 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20265876 | See source | Category A | XC02DDX070B002010104145 | NHSA |
| Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256405 | See source | Category A | XC02DDX070B002010104900 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20223226 | See source | Category A | XC02DDX070B002010105801 | NHSA |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | 国药准字H20249215 | See source | Category A | XC02DDX070B002010109552 | NHSA |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20264379 | See source | Category A | XC02DDX070B002010109910 | NHSA |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264923 | See source | Category A | XC02DDX070B002010183048 | NHSA |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263476 | See source | Category A | XC02DDX070B002010184534 | NHSA |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263476 | See source | Category A | XC02DDX070B002010284534 | NHSA |
| Caplin Steriles Limited | 国药准字HJ20260085 | See source | Category A | XC02DDX070B002010185310 | 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: 15 filings and 14 distinct first applicants.
Generic 15
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2503804 | Generic | 2025/10/28 | Not stated by source | CDE |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CYHS2600947 | Generic | 2026/04/24 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2602475 | Generic | 2026/10/10 | Not stated by source | CDE |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | CYHS2503741 | Generic | 2025/10/21 | Not stated by source | CDE |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized | CYHS2503444 | Generic | 2025/09/18 | Not stated by source | CDE |
| Hua Run Shuang He Pharma Co., Ltd. romanized | CYHS2503066 | Generic | 2025/08/20 | Not stated by source | CDE |
| Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized | CYHS2502341 | Generic | 2025/07/02 | Not stated by source | CDE |
| Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2502228 | Generic | 2025/06/20 | Not stated by source | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | CYHS2502213 | Generic | 2025/06/20 | Not stated by source | CDE |
| Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized | CYHS2502175 | Generic | 2025/06/18 | Not stated by source | CDE |
| Hebei Yi Pin Pharmaceutical Co., Ltd. romanized | CYHS2502011 | Generic | 2025/06/06 | Not stated by source | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2501982 | Generic | 2025/06/05 | Not stated by source | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2501981 | Generic | 2025/06/05 | Not stated by source | CDE |
| Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | CYHS2501159 | Generic | 2025/03/25 | Not stated by source | CDE |
| Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | CYHS2500578 | Generic | 2025/02/06 | 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 |
|---|---|---|---|---|---|
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CYHS2600947 | Generic | 2026/04/24 | Not stated by source | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2602475 | Generic | 2026/10/10 | Not stated by source | CDE |
Non-component matches: 17 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 硝普钠 · No verified English name | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized | Y20260000486 | I | Exact ingredient | 2026/08/18 | CDE |
| 硝普钠 · No verified English name | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | Y20250001347 | I | Exact ingredient | 2025/12/15 | CDE |
| 硝普钠 · No verified English name | Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20250000236 | A | Exact ingredient | 2026/09/11 | CDE |
| 硝普钠 · No verified English name | Anhui Pu Li Pharma Co., Ltd. romanized | Y20240001218 | A | Exact ingredient | 2026/03/26 | CDE |
| 硝普钠 · No verified English name | Shandong Chuan Cheng Pharmaceuticals Co., Ltd. romanized | Y20240000799 | A | Exact ingredient | 2026/10/31 | CDE |
| 硝普钠 · No verified English name | Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20240000362 | A | Exact ingredient | 2025/08/22 | CDE |
| 硝普钠 · No verified English name | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20240000094 | A | Exact ingredient | 2025/08/26 | CDE |
| 硝普钠 · No verified English name | Azico Biophore India Pvt Ltd | Y20230001195 | A | Exact ingredient | 2026/08/28 | CDE |
| 硝普钠 · No verified English name | Henan Zhong Shuai Pharma Co., Ltd. romanized | Y20220001337 | A | Exact ingredient | 2024/09/29 | CDE |
| 硝普钠 · No verified English name | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220001181 | A | Exact ingredient | 2025/12/20 | CDE |
| 硝普钠 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20210000083 | A | Exact ingredient | 2026/04/14 | CDE |
| 硝普钠 · No verified English name | San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | Y20190009710 | A | Exact ingredient | 2025/03/14 | CDE |
| 硝普钠 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20190007504 | A | Exact ingredient | 2025/03/01 | CDE |
| 硝普钠 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190005092 | A | Exact ingredient | 2025/07/29 | CDE |
| 硝普钠 · No verified English name | Kang Pu Pharma Co., Ltd. romanized | Y20190004573 | A | Exact ingredient | 2026/03/21 | CDE |
| 硝普钠 · No verified English name | Shanghai Di Ran Dan Cheng Pharmaceutical Co., Ltd. romanized | Y20190004349 | A | Exact ingredient | 2024/11/01 | CDE |
| 硝普钠 · No verified English name | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | Y20190003626 | A | Exact ingredient | — | CDE |
| 硝普钠 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190002726 | A | Exact ingredient | 2025/05/22 | CDE |
| 硝普钠 · No verified English name | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20190000020 | A | Exact ingredient | 2024/03/14 | CDE |
| 硝普钠 · No verified English name | San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | Y20170002000 | A | Exact ingredient | 2022/10/18 | CDE |
| 硝普钠 · No verified English name | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized | Y20260000897 | I | Exact ingredient | 2026/10/30 | 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.
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 ↗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 ↗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 ↗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 ↗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:
CYHS2602475
Fact date: 2026/10/10 · 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.
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