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Betamethasone Sodium Phosphate Injection

As of 13 November 2026, for Betamethasone Sodium Phosphate Injection, 5 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 25 holders.

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

Last 90 days: Accepted: 1 applicationNo longer listed under review: 1 application

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 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: 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
CELESTONE SCHERING CORP SUB SCHERING PLOUGH CORP NDA 017561 · Product no. 001 INJECTABLE INJECTION DISCONTINUED 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: 25 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 22 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Henan Li Hua Pharmaceutical Co., Ltd. romanizedHenan Run Hong Pharmaceutical Co., Ltd. romanized国药准字H202659642026/09/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Anhui Mei Lai Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202654472026/08/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanizedSichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202644842026/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202636892026/03/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanizedXi Nan Pharma Co., Ltd. romanized国药准字H202636062026/03/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanizedJilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H202635412026/03/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Zhe Bei Pharma Co., Ltd. romanizedZhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H202631582026/01/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedZhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H202630042026/01/05See sourceGeneric approved under the new chemical-drug registration classificationCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202561972025/12/09See sourceGeneric approved under the new chemical-drug registration classificationCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202561962025/12/09See sourceGeneric approved under the new chemical-drug registration classificationCDE
Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanizedYu Song Yuan Pharma Co., Ltd. romanized国药准字H202556432025/09/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedGuangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized国药准字H202550522025/07/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Shen Long Pharma Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202550172025/07/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Shen Long Pharma Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202550162025/07/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202542622025/05/27See sourceGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H202543632025/05/27See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hubei Min Kang Pharma Group Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202540242025/04/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yu Song Yuan Pharma Co., Ltd. romanizedYu Song Yuan Pharma Co., Ltd. romanized国药准字H202535832025/03/11See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shaanxi Li Cai Pharma Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202534172025/02/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202473072024/12/05See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanizedJin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H200583072024/12/05See 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H202494382024/11/22See 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H202444962024/07/30See sourceNot stated by sourceCDE
Beijing Bu Lin Bio Technology Co., Ltd. romanizedHua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202444872024/07/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanizedChengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H202444702024/07/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Chongqing Huapont Pharmaceutical Co., Ltd.Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H202438822024/06/04See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sui Cheng Pharma Co., Ltd. romanizedSui Cheng Pharma Co., Ltd. romanized国药准字H200649172023/08/29See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Sui Cheng Pharma Co., Ltd. romanizedSui Cheng Pharma Co., Ltd. romanized国药准字H200649172023/08/29See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedChengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H202659132026/09/08See 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: 27 distinct approval numbers and 22 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H20249438See sourceCategory BXH02ABB044B002010100874NHSA
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20243882See sourceCategory BXH02ABB044B002010101003NHSA
Jiangsu Shen Long Pharma Co., Ltd. romanized国药准字H20255016See sourceCategory BXH02ABB044B002010101478NHSA
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized国药准字H20058307See sourceCategory BXH02ABB044B002010101866NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H20264484See sourceCategory BXH02ABB044B002010102087NHSA
Yu Song Yuan Pharma Co., Ltd. romanized国药准字H20253583See sourceCategory BXH02ABB044B002010103163NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H20064917See sourceCategory BXH02ABB044B002010103204NHSA
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H20256197See sourceCategory BXH02ABB044B002010103216NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20254363See sourceCategory BXH02ABB044B002010104127NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20065249See sourceCategory BXH02ABB044B002010104207NHSA
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H20263004See sourceCategory BXH02ABB044B002010104735NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H20263606See sourceCategory BXH02ABB044B002010106286NHSA
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H20244496See sourceCategory BXH02ABB044B002010109910NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H20244470See sourceCategory BXH02ABB044B002010182338NHSA
Shaanxi Li Cai Pharma Co., Ltd. romanized国药准字H20253417See sourceCategory BXH02ABB044B002010183540NHSA
Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized国药准字H20254262See sourceCategory BXH02ABB044B002010183867NHSA
Beijing Liu Huan Pharma Co., Ltd. romanized国药准字H20244487See sourceCategory BXH02ABB044B002010183878NHSA
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247307See sourceCategory BXH02ABB044B002010184397NHSA
Anhui Mei Lai Pharma Co., Ltd. romanized国药准字H20265447See sourceCategory BXH02ABB044B002010184482NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255052See sourceCategory BXH02ABB044B002010184534NHSA
Hubei Min Kang Pharma Group Co., Ltd. romanized国药准字H20254024See sourceCategory BXH02ABB044B002010184564NHSA
Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263689See sourceCategory BXH02ABB044B002010184778NHSA
Chongqing Huapont Pharmaceutical Co., Ltd.国药准字H20243882See sourceCategory BXH02ABB044B002010201003NHSA
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized国药准字H20058307See sourceCategory BXH02ABB044B002010201866NHSA
Yu Song Yuan Pharma Co., Ltd. romanized国药准字H20253583See sourceCategory BXH02ABB044B002010203163NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H20064917See sourceCategory BXH02ABB044B002010203204NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20254363See sourceCategory BXH02ABB044B002010204127NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20065249See sourceCategory BXH02ABB044B002010204207NHSA
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H20263004See sourceCategory BXH02ABB044B002010204735NHSA
Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized国药准字H20244470See sourceCategory BXH02ABB044B002010282338NHSA
Shaanxi Li Cai Pharma Co., Ltd. romanized国药准字H20253417See sourceCategory BXH02ABB044B002010283540NHSA
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized国药准字H20247307See sourceCategory BXH02ABB044B002010284397NHSA
Anhui Mei Lai Pharma Co., Ltd. romanized国药准字H20265447See sourceCategory BXH02ABB044B002010284482NHSA
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized国药准字H20255052See sourceCategory BXH02ABB044B002010284534NHSA
Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized国药准字H20058307See sourceCategory BXH02ABB044B002010301866NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20254363See sourceCategory BXH02ABB044B002010304127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20254363See sourceCategory BXH02ABB044B002010404127NHSA
Jiangsu Shen Long Pharma Co., Ltd. romanized国药准字H20255017See sourceCategory BXH02ABB044B002020101478NHSA
Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized国药准字H20255643See sourceCategory BXH02ABB044B002020103163NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H20237102See sourceCategory BXH02ABB044B002020103204NHSA
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H20256196See sourceCategory BXH02ABB044B002020103216NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20065250See sourceCategory BXH02ABB044B002020104207NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H20237102See sourceCategory BXH02ABB044B002020203204NHSA
Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized国药准字H20065250See sourceCategory BXH02ABB044B002020204207NHSA

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: 5 filings and 5 distinct first applicants.

Generic 4 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanizedCYHS2601687Generic2026/07/15Not stated by sourceCDE
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2600995Generic2026/04/28Not stated by sourceCDE
Henan Run Hong Pharmaceutical Co., Ltd. romanizedCYHS2600316Generic2026/01/30Not stated by sourceCDE
Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanizedCYHS2502807Generic2025/08/04Not stated by sourceCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCYHB2601954Supplement2026/10/23Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanizedCYHS2601687Generic2026/07/15Not stated by sourceCDE
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedCYHS2600995Generic2026/04/28Not stated by sourceCDE
Henan Run Hong Pharmaceutical Co., Ltd. romanizedCYHS2600316Generic2026/01/30Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
倍他米松磷酸钠 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20240001492AExact ingredient2026/11/04CDE
倍他米松磷酸钠 · No verified English nameHenan Li Hua Pharmaceutical Co., Ltd. romanizedY20230000084AExact ingredient2025/10/27CDE
倍他米松磷酸钠 · No verified English nameCURIA SPAIN S.A.U.Y20230001012AExact ingredient2026/07/13CDE
倍他米松磷酸钠 · No verified English nameShanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanizedY20190009520AExact ingredient2025/02/20CDE
倍他米松磷酸钠 · No verified English nameZhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedY20190007551AExact ingredient2025/11/10CDE
倍他米松磷酸钠 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20190006978AExact ingredient2025/08/09CDE
倍他米松磷酸钠 · No verified English nameJin Yao Pharma Co., Ltd. romanizedY20170002316AExact ingredient2026/01/24CDE

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. 2026/11/06No longer listed under review

    Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized

    CYHS2500399

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

    Accepted: 2025/01/22

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

    View source ↗
  2. 2026/10/23Accepted

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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