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Matched- Active ingredients (original)
- RUXOLITINIB PHOSPHATE
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval2011/11/16
ANDA applications0
RLD applicantINCYTE CORP
Currently marketed products: 5 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| N202192-001 | JAKAFI | INCYTE CORP | TABLET | ORAL | RUXOLITINIB PHOSPHATE: EQ 5MG BASE | 2011/11/16 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202192-002 | JAKAFI | INCYTE CORP | TABLET | ORAL | RUXOLITINIB PHOSPHATE: EQ 10MG BASE | 2011/11/16 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202192-003 | JAKAFI | INCYTE CORP | TABLET | ORAL | RUXOLITINIB PHOSPHATE: EQ 15MG BASE | 2011/11/16 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202192-004 | JAKAFI | INCYTE CORP | TABLET | ORAL | RUXOLITINIB PHOSPHATE: EQ 20MG BASE | 2011/11/16 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202192-005 | JAKAFI | INCYTE CORP | TABLET | ORAL | RUXOLITINIB PHOSPHATE: EQ 25MG BASE | 2011/11/16 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2028/12/12This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2028/06/12
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| N202192-001 | 10016429 | 2028/06/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-001 | 10016429*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-001 | 7598257 | 2027/12/24 | Y / Y | U-3227 | — | openFDA ↗ |
| N202192-001 | 7598257*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-001 | 8415362 | 2027/12/24 | Y / Y | — | — | openFDA ↗ |
| N202192-001 | 8415362*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-001 | 8722693 | 2028/06/12 | Y / Y | — | — | openFDA ↗ |
| N202192-001 | 8722693*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-001 | 8822481 | 2028/06/12 | — / — | U-1573 | — | openFDA ↗ |
| N202192-001 | 8822481*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-001 | 8829013 | 2028/06/12 | — / — | U-1201 | — | openFDA ↗ |
| N202192-001 | 8829013*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-001 | 9079912 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-001 | 9079912*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-001 | 9814722 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-001 | 9814722*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 10016429 | 2028/06/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-002 | 10016429*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 7598257 | 2027/12/24 | Y / Y | U-3227 | — | openFDA ↗ |
| N202192-002 | 7598257*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-002 | 8415362 | 2027/12/24 | Y / Y | — | — | openFDA ↗ |
| N202192-002 | 8415362*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-002 | 8722693 | 2028/06/12 | Y / Y | — | — | openFDA ↗ |
| N202192-002 | 8722693*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 8822481 | 2028/06/12 | — / — | U-1573 | — | openFDA ↗ |
| N202192-002 | 8822481*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 8829013 | 2028/06/12 | — / — | U-1622 | — | openFDA ↗ |
| N202192-002 | 8829013*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 9079912 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-002 | 9079912*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-002 | 9814722 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-002 | 9814722*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 10016429 | 2028/06/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-003 | 10016429*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 7598257 | 2027/12/24 | Y / Y | U-3227 | — | openFDA ↗ |
| N202192-003 | 7598257*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-003 | 8415362 | 2027/12/24 | Y / Y | — | — | openFDA ↗ |
| N202192-003 | 8415362*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-003 | 8722693 | 2028/06/12 | Y / Y | — | — | openFDA ↗ |
| N202192-003 | 8722693*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 8822481 | 2028/06/12 | — / — | U-1573 | — | openFDA ↗ |
| N202192-003 | 8822481*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 8829013 | 2028/06/12 | — / — | U-1622 | — | openFDA ↗ |
| N202192-003 | 8829013*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 9079912 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-003 | 9079912*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-003 | 9814722 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-003 | 9814722*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 10016429 | 2028/06/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-004 | 10016429*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 7598257 | 2027/12/24 | Y / Y | U-3228 | — | openFDA ↗ |
| N202192-004 | 7598257*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-004 | 8415362 | 2027/12/24 | Y / Y | — | — | openFDA ↗ |
| N202192-004 | 8415362*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-004 | 8722693 | 2028/06/12 | Y / Y | — | — | openFDA ↗ |
| N202192-004 | 8722693*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 8822481 | 2028/06/12 | — / — | U-1573 | — | openFDA ↗ |
| N202192-004 | 8822481*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 8829013 | 2028/06/12 | — / — | U-1201 | — | openFDA ↗ |
| N202192-004 | 8829013*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 9079912 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-004 | 9079912*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-004 | 9814722 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-004 | 9814722*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 10016429 | 2028/06/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-005 | 10016429*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 7598257 | 2027/12/24 | Y / Y | U-3228 | — | openFDA ↗ |
| N202192-005 | 7598257*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-005 | 8415362 | 2027/12/24 | Y / Y | — | — | openFDA ↗ |
| N202192-005 | 8415362*PED | 2028/06/24 | — / — | — | — | openFDA ↗ |
| N202192-005 | 8722693 | 2028/06/12 | Y / Y | — | — | openFDA ↗ |
| N202192-005 | 8722693*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 8822481 | 2028/06/12 | — / — | U-1573 | — | openFDA ↗ |
| N202192-005 | 8822481*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 8829013 | 2028/06/12 | — / — | U-1201 | — | openFDA ↗ |
| N202192-005 | 8829013*PED | 2028/12/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 9079912 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-005 | 9079912*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
| N202192-005 | 9814722 | 2026/12/12 | — / — | U-3230 | — | openFDA ↗ |
| N202192-005 | 9814722*PED | 2027/06/12 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2029/03/22
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N202192-001 | M-285 | 2025/12/19 | openFDA ↗ |
| N202192-001 | ODE-238 | 2026/05/24 | openFDA ↗ |
| N202192-001 | ODE-373 | 2028/09/22 | openFDA ↗ |
| N202192-001 | PED | 2029/03/22 | openFDA ↗ |
| N202192-002 | M-285 | 2025/12/19 | openFDA ↗ |
| N202192-002 | ODE-238 | 2026/05/24 | openFDA ↗ |
| N202192-002 | ODE-373 | 2028/09/22 | openFDA ↗ |
| N202192-002 | PED | 2029/03/22 | openFDA ↗ |
| N202192-003 | M-285 | 2025/12/19 | openFDA ↗ |
| N202192-003 | ODE-238 | 2026/05/24 | openFDA ↗ |
| N202192-003 | ODE-373 | 2028/09/22 | openFDA ↗ |
| N202192-003 | PED | 2029/03/22 | openFDA ↗ |
| N202192-004 | M-285 | 2025/12/19 | openFDA ↗ |
| N202192-004 | ODE-238 | 2026/05/24 | openFDA ↗ |
| N202192-004 | ODE-373 | 2028/09/22 | openFDA ↗ |
| N202192-004 | PED | 2029/03/22 | openFDA ↗ |
| N202192-005 | M-285 | 2025/12/19 | openFDA ↗ |
| N202192-005 | ODE-238 | 2026/05/24 | openFDA ↗ |
| N202192-005 | ODE-373 | 2028/09/22 | openFDA ↗ |
| N202192-005 | PED | 2029/03/22 | openFDA ↗ |
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265691See source | 2026/08/25 | Official source ↗ |
| Zhejiang Qi Zheng Pharma Co., Ltd. romanized | 国药准字H20265641See source | 2026/08/18 | Official source ↗ |
| Zhejiang Qi Zheng Pharma Co., Ltd. romanized | 国药准字H20265642See source | 2026/08/18 | Official source ↗ |
| Zhejiang Qi Zheng Pharma Co., Ltd. romanized | 国药准字H20265640See source | 2026/08/18 | Official source ↗ |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | 国药准字H20264487See source | 2026/05/19 | Official source ↗ |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | 国药准字H20264492See source | 2026/05/19 | Official source ↗ |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20263118See source | 2026/01/14 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | 2026/01/05 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | 2026/01/05 | Official source ↗ |
| NANJING ZENKOM PHARMACEUTICAL CO.,LTD. | 国药准字H20256448See source | 2025/12/30 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H20256441See source | 2025/12/30 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20249398See source | 2024/11/15 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265696See source | 2026/08/25 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265692See source | 2026/08/25 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265694See source | 2026/08/25 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265693See source | 2026/08/25 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265695See source | 2026/08/25 | Official source ↗ |
NHSA approval numbers 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265691See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | — | Official source ↗ |
| Novartis Europharm Limited | 国药准字HJ20170134See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | — | Official source ↗ |
| Novartis Europharm Limited | 国药准字HJ20170133See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | — | Official source ↗ |
| Novartis Europharm Limited | 国药准字HJ20170134See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | — | Official source ↗ |
| Novartis Europharm Limited | H201701325mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263015See source | — | Official source ↗ |
| Novartis Europharm Limited | 国药准字HJ20170133See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265692See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017013015mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | — | Official source ↗ |
| Novartis Europharm Limited | H2017013115mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017013015mg | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | — | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20263014See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20265693See source | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017012820mg | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017012720mg | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017012820mg | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H2017012720mg | — | Official source ↗ |
Under review 27
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602317 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602316 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602315 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602314 | 2026/09/17 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2201058 | 2022/07/14 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2201057 | 2022/07/14 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | CYHS2201056 | 2022/07/14 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2600982 | 2026/04/28 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602561 | 2026/10/19 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602560 | 2026/10/19 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602559 | 2026/10/19 | Official source ↗ |
| Shandong Luo Xin Pharma Group Co., Ltd. romanized | CYHS2602129 | 2026/08/26 | Official source ↗ |
| MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION II ); Sino Universal Pharmaceutical Co. Ltd | JYHS2600015 | 2026/08/12 | Official source ↗ |
| Novartis Europharm Limited; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing LLC | JYHB2600374 | 2026/07/10 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | CYHS2600913 | 2026/04/21 | Official source ↗ |
| Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2600763 | 2026/04/01 | Official source ↗ |
| YaoPharma Co., Ltd. | CYHS2600706 | 2026/03/24 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | CYHS2504053 | 2025/11/25 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | CYHS2503012 | 2025/08/15 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | CYHS2503011 | 2025/08/15 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | CYHS2503010 | 2025/08/15 | Official source ↗ |
| Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized | CYHS2500756 | 2025/02/17 | Official source ↗ |
| Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized | CYHS2400363 | 2024/01/27 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602615 | 2026/10/26 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602614 | 2026/10/26 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602613 | 2026/10/26 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CYHS2602630 | 2026/10/27 | Official source ↗ |
Generic-filing companies this year 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602317 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602316 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602315 | 2026/09/17 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | CYHS2602314 | 2026/09/17 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2600982 | 2026/04/28 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602561 | 2026/10/19 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602560 | 2026/10/19 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2602559 | 2026/10/19 | Official source ↗ |
| Shandong Luo Xin Pharma Group Co., Ltd. romanized | CYHS2602129 | 2026/08/26 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | CYHS2600913 | 2026/04/21 | Official source ↗ |
| Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2600763 | 2026/04/01 | Official source ↗ |
| YaoPharma Co., Ltd. | CYHS2600706 | 2026/03/24 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602615 | 2026/10/26 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602614 | 2026/10/26 | Official source ↗ |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized | CYHS2602613 | 2026/10/26 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CYHS2602630 | 2026/10/27 | Official source ↗ |
API companies with A status 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. | Y20250000174 | 2026/09/14 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20250000039 | 2026/07/01 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20250000073 | 2026/09/14 | Official source ↗ |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20240001324 | 2026/08/07 | Official source ↗ |
| Hebei Ding Tai Pharmaceutical Co., Ltd. romanized | Y20240001105 | 2026/06/16 | Official source ↗ |
| Zhejiang Ao Xiang Pharma Co., Ltd. romanized | Y20240001130 | 2026/03/30 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20240000491 | 2025/12/30 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20230000729 | 2025/04/07 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20230000288 | 2025/03/21 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20230000081 | 2024/12/13 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20220000951 | 2025/11/11 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 50-55 · 2022/01/14
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