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Matched- Active ingredients (original)
- IBRUTINIB
- Dosage form (original)
- CAPSULE
- 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 approval2013/11/13
ANDA applications2
RLD applicantPHARMACYCLICS LLC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A211182-001 | IBRUTINIB | HETERO LABS LTD UNIT V | CAPSULE | ORAL | IBRUTINIB: 140MG | 2026/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211344-001 | IBRUTINIB | ZYDUS LIFESCIENCES GLOBAL FZE | CAPSULE | ORAL | IBRUTINIB: 70MG | 2021/03/31 | N / N | DISCONTINUED | openFDA ↗ |
| A211344-002 | IBRUTINIB | ZYDUS LIFESCIENCES GLOBAL FZE | CAPSULE | ORAL | IBRUTINIB: 140MG | 2021/03/31 | N / N | DISCONTINUED | openFDA ↗ |
| N205552-001 | IMBRUVICA | PHARMACYCLICS LLC | CAPSULE | ORAL | IBRUTINIB: 140MG | 2013/11/13 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205552-002 | IMBRUVICA | PHARMACYCLICS LLC | CAPSULE | ORAL | IBRUTINIB: 70MG | 2017/12/20 | Y / N | 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 expiration2035/04/24This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2033/10/30
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 |
|---|---|---|---|---|---|---|
| N205552-001 | 10004746 | 2031/06/03 | — / — | U-1684 | — | openFDA ↗ |
| N205552-001 | 10004746*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10016435 | 2031/06/03 | — / — | U-1650 | — | openFDA ↗ |
| N205552-001 | 10016435*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10106548 | 2033/06/03 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 10106548*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10125140 | 2033/06/03 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 10125140*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10294231 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 10294231*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10294232 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 10294232*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10463668 | 2034/10/24 | — / — | U-2654 | — | openFDA ↗ |
| N205552-001 | 10463668*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10478439 | 2031/06/03 | — / — | U-3422 | — | openFDA ↗ |
| N205552-001 | 10478439*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10695350 | 2034/10/24 | — / — | U-2846 | — | openFDA ↗ |
| N205552-001 | 10695350*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10751342 | 2031/06/03 | — / — | U-2943 | — | openFDA ↗ |
| N205552-001 | 10751342*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10752634 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 10752634*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 10961251 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 10961251*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 11672803 | 2031/06/03 | — / — | U-1946 | — | openFDA ↗ |
| N205552-001 | 7514444 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 7514444*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8008309 | 2027/11/13 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 8008309*PED | 2028/05/13 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8476284 | 2026/12/28 | — / — | U-1650 | — | openFDA ↗ |
| N205552-001 | 8476284*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8497277 | 2026/12/28 | — / — | U-3422 | — | openFDA ↗ |
| N205552-001 | 8497277*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8563563 | 2027/04/26 | — / — | U-1491 | — | openFDA ↗ |
| N205552-001 | 8563563*PED | 2027/10/26 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8697711 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 8697711*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8703780 | 2026/12/28 | — / — | U-1491 | — | openFDA ↗ |
| N205552-001 | 8703780*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8735403 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 8735403*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8754091 | 2026/12/28 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 8754091*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8952015 | 2026/12/28 | — / — | U-1946 | — | openFDA ↗ |
| N205552-001 | 8952015*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8957079 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 8957079*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 8999999 | 2031/06/03 | — / — | U-1684 | — | openFDA ↗ |
| N205552-001 | 8999999*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9125889 | 2031/06/03 | — / — | U-1745 | — | openFDA ↗ |
| N205552-001 | 9125889*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9181257 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 9181257*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9296753 | 2033/10/30 | Y / Y | — | — | openFDA ↗ |
| N205552-001 | 9296753*PED | 2034/04/30 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9540382 | 2033/08/18 | — / — | U-1684 | — | openFDA ↗ |
| N205552-001 | 9540382*PED | 2034/02/18 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9713617 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-001 | 9713617*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9725455 | 2033/06/03 | Y / — | — | — | openFDA ↗ |
| N205552-001 | 9725455*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9795604 | 2034/10/24 | — / — | U-2150 | — | openFDA ↗ |
| N205552-001 | 9795604*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9801881 | 2031/06/03 | — / — | U-1491 | — | openFDA ↗ |
| N205552-001 | 9801881*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-001 | 9801883 | 2031/06/03 | — / — | U-2159 | — | openFDA ↗ |
| N205552-001 | 9801883*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10004746 | 2031/06/03 | — / — | U-2241 | — | openFDA ↗ |
| N205552-002 | 10004746*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10016435 | 2031/06/03 | — / — | U-1650 | — | openFDA ↗ |
| N205552-002 | 10016435*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10106548 | 2033/06/03 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 10106548*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10125140 | 2033/06/03 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 10125140*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10294231 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-002 | 10294231*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10294232 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-002 | 10294232*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10463668 | 2034/10/24 | — / — | U-2654 | — | openFDA ↗ |
| N205552-002 | 10463668*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10478439 | 2031/06/03 | — / — | U-3422 | — | openFDA ↗ |
| N205552-002 | 10478439*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10695350 | 2034/10/24 | — / — | U-2846 | — | openFDA ↗ |
| N205552-002 | 10695350*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10751342 | 2031/06/03 | — / — | U-2943 | — | openFDA ↗ |
| N205552-002 | 10751342*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 10961251 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-002 | 10961251*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 11672803 | 2031/06/03 | — / — | U-1684 | — | openFDA ↗ |
| N205552-002 | 7514444 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 7514444*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8008309 | 2027/11/13 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 8008309*PED | 2028/05/13 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8476284 | 2026/12/28 | — / — | U-1650 | — | openFDA ↗ |
| N205552-002 | 8476284*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8497277 | 2026/12/28 | — / — | U-3422 | — | openFDA ↗ |
| N205552-002 | 8497277*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8563563 | 2027/04/26 | — / — | U-1491 | — | openFDA ↗ |
| N205552-002 | 8563563*PED | 2027/10/26 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8697711 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 8697711*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8703780 | 2026/12/28 | — / — | U-1491 | — | openFDA ↗ |
| N205552-002 | 8703780*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8735403 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 8735403*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8754091 | 2026/12/28 | — / Y | — | — | openFDA ↗ |
| N205552-002 | 8754091*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8952015 | 2026/12/28 | — / — | U-1491 | — | openFDA ↗ |
| N205552-002 | 8952015*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8957079 | 2026/12/28 | Y / Y | — | — | openFDA ↗ |
| N205552-002 | 8957079*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 8999999 | 2031/06/03 | — / — | U-1946 | — | openFDA ↗ |
| N205552-002 | 8999999*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9125889 | 2031/06/03 | — / — | U-1650 | — | openFDA ↗ |
| N205552-002 | 9125889*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9181257 | 2026/12/28 | Y / — | — | — | openFDA ↗ |
| N205552-002 | 9181257*PED | 2027/06/28 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9296753 | 2033/10/30 | Y / — | — | — | openFDA ↗ |
| N205552-002 | 9296753*PED | 2034/04/30 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9540382 | 2033/08/18 | — / — | U-1650 | — | openFDA ↗ |
| N205552-002 | 9540382*PED | 2034/02/18 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9713617 | 2033/06/03 | — / Y | — | — | openFDA ↗ |
| N205552-002 | 9713617*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9725455 | 2033/06/03 | Y / — | — | — | openFDA ↗ |
| N205552-002 | 9725455*PED | 2033/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9795604 | 2034/10/24 | — / — | U-2969 | — | openFDA ↗ |
| N205552-002 | 9795604*PED | 2035/04/24 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9801881 | 2031/06/03 | — / — | U-1491 | — | openFDA ↗ |
| N205552-002 | 9801881*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
| N205552-002 | 9801883 | 2031/06/03 | — / — | U-2159 | — | openFDA ↗ |
| N205552-002 | 9801883*PED | 2031/12/03 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2029/08/24
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N205552-001 | NPP | 2025/08/24 | openFDA ↗ |
| N205552-001 | ODE-405 | 2029/08/24 | openFDA ↗ |
| N205552-001 | PED | 2026/02/24 | openFDA ↗ |
| N205552-002 | NPP | 2025/08/24 | openFDA ↗ |
| N205552-002 | ODE-405 | 2029/08/24 | openFDA ↗ |
| N205552-002 | PED | 2026/02/24 | 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 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20264337140mg | 2026/05/19 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20264339140mg | 2026/05/19 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20263693140mg | 2026/03/25 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20254986140mg | 2025/07/29 | Official source ↗ |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | 国药准字H20254682140mg | 2025/06/30 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H20253113140mg | 2025/01/08 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20249566140mg | 2024/12/01 | Official source ↗ |
| M/s Natco Pharma Limited | 国药准字HJ20240120140mg | 2024/10/29 | Official source ↗ |
| Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20223719140mg | 2022/10/11 | Official source ↗ |
| Pharmacyclics LLC | H20170350140mg | 2017/08/24 | Official source ↗ |
NHSA approval numbers 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20266103140mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20263693140mg | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20254986140mg | — | Official source ↗ |
| Janssen-Cilag International NV | 国药准字HJ20181066140mg | — | Official source ↗ |
| Janssen-Cilag International NV | 国药准字HJ20181066140mg | — | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20264337140mg | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CYHS2503756 | 2025/10/22 | Official source ↗ |
| Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG | JYHB2600561 | 2026/10/21 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602368 | 2026/09/21 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd.; Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | CYHB2601777 | 2026/09/21 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd.; Beijing Ya Bao Bio Pharma Co., Ltd. romanized | CYHB2601763 | 2026/09/20 | Official source ↗ |
| Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG; Xian-Janssen Pharmaceutical Ltd. | JYHZ2600188 | 2026/08/05 | Official source ↗ |
| Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanized | CYHS2601071 | 2026/05/12 | Official source ↗ |
| Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2503353 | 2025/09/10 | Official source ↗ |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | CYHB2602007 | 2026/11/05 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jin Hong Pharma Co., Ltd. romanized | CYHS2602368 | 2026/09/21 | Official source ↗ |
| Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanized | CYHS2601071 | 2026/05/12 | Official source ↗ |
API companies with A status 14
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20240001561 | 2026/06/04 | Official source ↗ |
| Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20240001142 | 2026/10/29 | Official source ↗ |
| Xuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanized | Y20240001011 | 2026/06/11 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240000915 | 2026/04/14 | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | Y20240000629 | 2026/09/21 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20240000254 | 2025/11/10 | Official source ↗ |
| Jin Hong Pharma Co., Ltd. romanized | Y20240000272 | 2026/01/08 | Official source ↗ |
| Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20230000989 | 2026/08/21 | Official source ↗ |
| Guangdong Lai Fu Shi Pharmaceutical Technology Co., Ltd. romanized | Y20230001268 | 2026/09/09 | Official source ↗ |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | Y20230000804 | 2025/01/26 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20230000444 | 2025/04/26 | Official source ↗ |
| Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20230000290 | 2025/01/12 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20210001234 | 2026/03/14 | Official source ↗ |
| Xian Sheng Pharma Co., Ltd. romanized | Y20200001176 | 2024/01/17 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/14 06:44
- Chemical Drug Catalog
- 2026/11/14 06:40
- API registration records
- 2026/11/14 06:43
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/14 08:10 · 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: 2026/11/14 18:39 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 57-48 · 2022/09/13
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