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Hydrocortisone Sodium Succinate for Injection

As of 13 November 2026, for Hydrocortisone Sodium Succinate for Injection, 16 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 10 holders.

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

Listed in the US FDA Orange Book as SOLU-CORTEF (NDA 009866, PHARMACIA AND UPJOHN CO).

Last 90 days: No longer listed under review: 2 applications

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 1 of 1 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: for 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
SOLU-CORTEF PHARMACIA AND UPJOHN CO NDA 009866 · Product no. 001, 002, 003, 004 INJECTABLE INJECTION HUMAN PRESCRIPTION DRUG Approved prior to 1982 (exact date not listed)

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

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: 10 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 6 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanizedMa An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized国药准字H202658632026/09/02See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanizedSichuan Hui Yu Pharmaceutical Co., Ltd. romanized国药准字H202646562026/06/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanizedLiaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H202644102026/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Changzhou Si Yao Pharmaceutical Co., Ltd. romanizedChangzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H200932932026/05/11See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202630392026/01/05See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedYan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H200843192025/04/29See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedYan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H200843182025/04/29See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202538622025/04/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202538632025/04/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedFu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H200586532024/08/01See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDTianjin Bio Chemical Pharmaceutical Co., Ltd. romanized国药准字H120204932024/03/28See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDTianjin Bio Chemical Pharmaceutical Co., Ltd. romanized国药准字H120204862024/03/28See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedFu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H200586542024/01/22See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Mu Yuan (Anhui) Pharma Co., Ltd. romanizedHainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202662772026/10/13See sourceGeneric approved under the new chemical-drug registration classificationCDE
Mu Yuan (Anhui) Pharma Co., Ltd. romanizedHainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202662762026/10/13See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanizedSichuan Hui Yu Pharmaceutical Co., Ltd. romanized国药准字H202646552026/06/10See 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: 18 distinct approval numbers and 11 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
TIANJIN LISHENG PHARMACEUTICAL CO., LTD国药准字H12020486See sourceCategory AXH02ABQ060B001010100918NHSA
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20253862See sourceCategory AXH02ABQ060B001010100952NHSA
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H200932930.05gCategory AXH02ABQ060B001010101389NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058654See sourceCategory AXH02ABQ060B001010101877NHSA
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H20084318See sourceCategory AXH02ABQ060B001010104233NHSA
Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263039See sourceCategory AXH02ABQ060B001010183817NHSA
Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized国药准字H20264410See sourceCategory AXH02ABQ060B001010184112NHSA
Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized国药准字H20265863See sourceCategory AXH02ABQ060B001010184659NHSA
Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20265756See sourceCategory AXH02ABQ060B001010184896NHSA
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20264655See sourceCategory AXH02ABQ060B001010185135NHSA
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H200932930.05gCategory AXH02ABQ060B001010201389NHSA
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H20084318See sourceCategory AXH02ABQ060B001010204233NHSA
Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263039See sourceCategory AXH02ABQ060B001010283817NHSA
Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized国药准字H20265863See sourceCategory AXH02ABQ060B001010284659NHSA
TIANJIN LISHENG PHARMACEUTICAL CO., LTD国药准字H12020493See sourceCategory AXH02ABQ060B001020100918NHSA
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20253863See sourceCategory AXH02ABQ060B001020100952NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058653See sourceCategory AXH02ABQ060B001020101877NHSA
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H20084319See sourceCategory AXH02ABQ060B001020104233NHSA
Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20265757See sourceCategory AXH02ABQ060B001020184896NHSA
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H20264656See sourceCategory AXH02ABQ060B001020185135NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058653See sourceCategory AXH02ABQ060B001020201877NHSA
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized国药准字H20084319See sourceCategory AXH02ABQ060B001020204233NHSA
TIANJIN LISHENG PHARMACEUTICAL CO., LTD国药准字H12020486See sourceCategory AXH02ABQ060B001030100918NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058654See sourceCategory AXH02ABQ060B001030101877NHSA
TIANJIN LISHENG PHARMACEUTICAL CO., LTD国药准字H12020493See sourceCategory AXH02ABQ060B001030200918NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058653See sourceCategory AXH02ABQ060B001040101877NHSA
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized国药准字H20058654See sourceCategory AXH02ABQ060B001050101877NHSA
Mu Yuan (Anhui) Pharma Co., Ltd. romanized国药准字H20266276See sourceCategory AXH02ABQ060B001010185656NHSA
Mu Yuan (Anhui) Pharma Co., Ltd. romanized国药准字H20266276See sourceCategory AXH02ABQ060B001010285656NHSA
Mu Yuan (Anhui) Pharma Co., Ltd. romanized国药准字H20266277See sourceCategory AXH02ABQ060B001020185656NHSA
Mu Yuan (Anhui) Pharma Co., Ltd. romanized国药准字H20266277See sourceCategory AXH02ABQ060B001020285656NHSA

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: 16 filings and 10 distinct first applicants.

Generic 16

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2502416Generic2025/07/08Not stated by sourceCDE
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601653Generic2026/07/10Not stated by sourceCDE
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601652Generic2026/07/10Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS2601434Generic2026/06/17Not stated by sourceCDE
Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanizedCYHS2600644Generic2026/03/11Not stated by sourceCDE
Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS2600513Generic2026/02/25Not stated by sourceCDE
Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanizedCYHS2503584Generic2025/09/30Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS2503087Generic2025/08/23Not stated by sourceCDE
Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS2503086Generic2025/08/23Not stated by sourceCDE
Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanizedCYHS2502300Generic2025/06/27Not stated by sourceCDE
Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shenyang Guang Da Pharmaceutical Co., Ltd. romanizedCYHS2502100Generic2025/06/12Not stated by sourceCDE
Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shenyang Guang Da Pharmaceutical Co., Ltd. romanizedCYHS2502099Generic2025/06/12Not stated by sourceCDE
Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS2501100Generic2025/03/18Not stated by sourceCDE
Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS2501099Generic2025/03/18Not stated by sourceCDE
Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2402621Generic2024/08/13Not stated by sourceCDE
Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2402620Generic2024/08/13Not stated by sourceCDE
New generic filings in 2026

Loaded records: 5 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601653Generic2026/07/10Not stated by sourceCDE
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601652Generic2026/07/10Not stated by sourceCDE
Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanizedCYHS2601434Generic2026/06/17Not stated by sourceCDE
Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanizedCYHS2600644Generic2026/03/11Not stated by sourceCDE
Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS2600513Generic2026/02/25Not stated by sourceCDE
API registrations

Non-component matches: 6 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
氢化可的松琥珀酸钠 · No verified English nameARIHANTANAM LIFE CARE PVT. LTD.Y20250001230IExact ingredient2025/12/18CDE
氢化可的松琥珀酸钠 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20250001095IExact ingredient2025/10/17CDE
氢化可的松琥珀酸钠 · No verified English nameTianjin Xin Yi Jin Jin Pharma Co., Ltd. romanizedY20250000227AExact ingredient2026/09/04CDE
氢化可的松琥珀酸钠 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20250000198AExact ingredient2026/09/08CDE
氢化可的松琥珀酸钠 · No verified English nameChangzhou Si Yao Pharmaceutical Co., Ltd. romanizedY20240001012AExact ingredient2026/03/02CDE
氢化可的松琥珀酸钠 · No verified English nameNEWCHEM S.P.A.Y20240000180IExact ingredient2024/07/09CDE
氢化可的松琥珀酸钠 · No verified English nameJin Yao Pharma Co., Ltd. romanizedY20220000589AExact ingredient2024/09/30CDE
氢化可的松琥珀酸钠 · No verified English nameHenan Li Hua Pharmaceutical Co., Ltd. romanizedY20190009439AExact ingredient2026/07/09CDE
氢化可的松琥珀酸钠 · No verified English nameTianjin Bio Chemical Pharmaceutical Co., Ltd. romanizedY20190007427AExact ingredient2024/08/15CDE
氢化可的松琥珀酸钠 · No verified English nameHenan Li Hua Pharmaceutical Co., Ltd. romanizedY20190000287IExact ingredient2019/05/17CDE

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. 2026/11/05No longer listed under review

    Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized

    CYHS2403585

    Fact date: 2026/11/05 · Site observation date: 2026/11/05

    Accepted: 2024/10/24

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

    View source ↗
  2. 2026/11/05No longer listed under review

    Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized

    CYHS2403584

    Fact date: 2026/11/05 · Site observation date: 2026/11/05

    Accepted: 2024/10/24

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

    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.

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