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Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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) |
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.
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: 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | Henan Run Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20265964 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Mei Lai Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20265447 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264484 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20263689 | 2026/03/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | Xi Nan Pharma Co., Ltd. romanized | 国药准字H20263606 | 2026/03/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20263541 | 2026/03/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263158 | 2026/01/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004 | 2026/01/05 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256197 | 2025/12/09 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256196 | 2025/12/09 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized | Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20255643 | 2025/09/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20255052 | 2025/07/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20255017 | 2025/07/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20255016 | 2025/07/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20254262 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20254024 | 2025/04/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yu Song Yuan Pharma Co., Ltd. romanized | Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583 | 2025/03/11 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20253417 | 2025/02/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20247307 | 2024/12/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20058307 | 2024/12/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20249438 | 2024/11/22 | 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H20244496 | 2024/07/30 | See source | Not stated by source | CDE |
| Beijing Bu Lin Bio Technology Co., Ltd. romanized | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20244487 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470 | 2024/07/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882 | 2024/06/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917 | 2023/08/29 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917 | 2023/08/29 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20265913 | 2026/09/08 | 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: 27 distinct approval numbers and 22 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20249438 | See source | Category B | XH02ABB044B002010100874 | NHSA |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882 | See source | Category B | XH02ABB044B002010101003 | NHSA |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255016 | See source | Category B | XH02ABB044B002010101478 | NHSA |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307 | See source | Category B | XH02ABB044B002010101866 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264484 | See source | Category B | XH02ABB044B002010102087 | NHSA |
| Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583 | See source | Category B | XH02ABB044B002010103163 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917 | See source | Category B | XH02ABB044B002010103204 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256197 | See source | Category B | XH02ABB044B002010103216 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363 | See source | Category B | XH02ABB044B002010104127 | NHSA |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065249 | See source | Category B | XH02ABB044B002010104207 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004 | See source | Category B | XH02ABB044B002010104735 | NHSA |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H20263606 | See source | Category B | XH02ABB044B002010106286 | NHSA |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20244496 | See source | Category B | XH02ABB044B002010109910 | NHSA |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470 | See source | Category B | XH02ABB044B002010182338 | NHSA |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20253417 | See source | Category B | XH02ABB044B002010183540 | NHSA |
| Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized | 国药准字H20254262 | See source | Category B | XH02ABB044B002010183867 | NHSA |
| Beijing Liu Huan Pharma Co., Ltd. romanized | 国药准字H20244487 | See source | Category B | XH02ABB044B002010183878 | NHSA |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247307 | See source | Category B | XH02ABB044B002010184397 | NHSA |
| Anhui Mei Lai Pharma Co., Ltd. romanized | 国药准字H20265447 | See source | Category B | XH02ABB044B002010184482 | NHSA |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255052 | See source | Category B | XH02ABB044B002010184534 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20254024 | See source | Category B | XH02ABB044B002010184564 | NHSA |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263689 | See source | Category B | XH02ABB044B002010184778 | NHSA |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882 | See source | Category B | XH02ABB044B002010201003 | NHSA |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307 | See source | Category B | XH02ABB044B002010201866 | NHSA |
| Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583 | See source | Category B | XH02ABB044B002010203163 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917 | See source | Category B | XH02ABB044B002010203204 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363 | See source | Category B | XH02ABB044B002010204127 | NHSA |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065249 | See source | Category B | XH02ABB044B002010204207 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004 | See source | Category B | XH02ABB044B002010204735 | NHSA |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470 | See source | Category B | XH02ABB044B002010282338 | NHSA |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20253417 | See source | Category B | XH02ABB044B002010283540 | NHSA |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247307 | See source | Category B | XH02ABB044B002010284397 | NHSA |
| Anhui Mei Lai Pharma Co., Ltd. romanized | 国药准字H20265447 | See source | Category B | XH02ABB044B002010284482 | NHSA |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255052 | See source | Category B | XH02ABB044B002010284534 | NHSA |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307 | See source | Category B | XH02ABB044B002010301866 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363 | See source | Category B | XH02ABB044B002010304127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363 | See source | Category B | XH02ABB044B002010404127 | NHSA |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255017 | See source | Category B | XH02ABB044B002020101478 | NHSA |
| Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized | 国药准字H20255643 | See source | Category B | XH02ABB044B002020103163 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20237102 | See source | Category B | XH02ABB044B002020103204 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256196 | See source | Category B | XH02ABB044B002020103216 | NHSA |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065250 | See source | Category B | XH02ABB044B002020104207 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20237102 | See source | Category B | XH02ABB044B002020203204 | NHSA |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065250 | See source | Category B | XH02ABB044B002020204207 | 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: 5 filings and 5 distinct first applicants.
Generic 4 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | CYHS2601687 | Generic | 2026/07/15 | Not stated by source | CDE |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2600995 | Generic | 2026/04/28 | Not stated by source | CDE |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | CYHS2600316 | Generic | 2026/01/30 | Not stated by source | CDE |
| Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2502807 | Generic | 2025/08/04 | Not stated by source | CDE |
| 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. romanized | CYHB2601954 | Supplement | 2026/10/23 | Not stated by source | CDE |
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | CYHS2601687 | Generic | 2026/07/15 | Not stated by source | CDE |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2600995 | Generic | 2026/04/28 | Not stated by source | CDE |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | CYHS2600316 | Generic | 2026/01/30 | Not stated by source | CDE |
Non-component matches: 7 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 倍他米松磷酸钠 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20240001492 | A | Exact ingredient | 2026/11/04 | CDE |
| 倍他米松磷酸钠 · No verified English name | Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20230000084 | A | Exact ingredient | 2025/10/27 | CDE |
| 倍他米松磷酸钠 · No verified English name | CURIA SPAIN S.A.U. | Y20230001012 | A | Exact ingredient | 2026/07/13 | CDE |
| 倍他米松磷酸钠 · No verified English name | Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | Y20190009520 | A | Exact ingredient | 2025/02/20 | CDE |
| 倍他米松磷酸钠 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20190007551 | A | Exact ingredient | 2025/11/10 | CDE |
| 倍他米松磷酸钠 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20190006978 | A | Exact ingredient | 2025/08/09 | CDE |
| 倍他米松磷酸钠 · No verified English name | Jin Yao Pharma Co., Ltd. romanized | Y20170002316 | A | Exact ingredient | 2026/01/24 | 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.
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 ↗CYHB2601954
Fact date: 2026/10/23 · Site observation date: 2026/10/24
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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