Monthly
US$200
Billed every month
Sign in to subscribeUpadacitinib Sustained-release Tablets
Matched- Active ingredients (original)
- UPADACITINIB
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- 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 approval2019/08/16
ANDA applications0
RLD applicantABBVIE INC
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 |
|---|---|---|---|---|---|---|---|---|---|
| N211675-001 | RINVOQ | ABBVIE INC | TABLET, EXTENDED RELEASE | ORAL | UPADACITINIB: 15MG | 2019/08/16 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N211675-002 | RINVOQ | ABBVIE INC | TABLET, EXTENDED RELEASE | ORAL | UPADACITINIB: 30MG | 2022/01/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N211675-003 | RINVOQ | ABBVIE INC | TABLET, EXTENDED RELEASE | ORAL | UPADACITINIB: 45MG | 2022/03/16 | 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 expiration2038/03/09
Substance patent expiration (DS flag)2036/10/17
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 |
|---|---|---|---|---|---|---|
| N211675-001 | 10519164 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 10597400 | 2036/10/17 | — / — | U-3255 | — | openFDA ↗ |
| N211675-001 | 10981923 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-001 | 10981924 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 10995095 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-001 | 11186584 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-001 | 11198697 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 11365198 | 2036/10/17 | — / — | U-3275 | — | openFDA ↗ |
| N211675-001 | 11512092 | 2036/10/17 | — / — | U-3371 | — | openFDA ↗ |
| N211675-001 | 11524964 | 2036/10/17 | — / — | U-3371 | — | openFDA ↗ |
| N211675-001 | 11535624 | 2036/10/17 | — / — | U-3255 | — | openFDA ↗ |
| N211675-001 | 11535625 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-001 | 11564922 | 2038/03/09 | — / — | U-4303 | — | openFDA ↗ |
| N211675-001 | 11607411 | 2038/03/09 | — / — | U-3341 | — | openFDA ↗ |
| N211675-001 | 11661425 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 11680069 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 11718627 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 11767326 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-001 | 11773105 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 11773106 | 2036/10/17 | — / — | U-3371 | — | openFDA ↗ |
| N211675-001 | 11780847 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 11780848 | 2036/10/17 | — / — | U-3371 | — | openFDA ↗ |
| N211675-001 | 11787815 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 11795175 | 2036/10/17 | — / — | U-3255 | — | openFDA ↗ |
| N211675-001 | 11976077 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-001 | 11993605 | 2036/10/17 | — / — | U-3946 | — | openFDA ↗ |
| N211675-001 | 11993606 | 2036/10/17 | — / — | U-3487 | — | openFDA ↗ |
| N211675-001 | 12077545 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 12103933 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 12110297 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | 12110298 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 12365689 | 2036/10/17 | — / — | U-3945 | — | openFDA ↗ |
| N211675-001 | 12570664 | 2036/10/17 | — / — | U-4454 | — | openFDA ↗ |
| N211675-001 | 8962629 | 2031/01/15 | Y / — | U-3945 | — | openFDA ↗ |
| N211675-001 | 9951080 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-001 | 9963459 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-001 | RE47221 | 2033/08/16 | Y / — | — | — | openFDA ↗ |
| N211675-002 | 10344036 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 10550126 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-002 | 10730883 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 10981923 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-002 | 10981924 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 11186584 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-002 | 11198697 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 11535626 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-002 | 11564922 | 2038/03/09 | — / — | U-3624 | — | openFDA ↗ |
| N211675-002 | 11607411 | 2038/03/09 | — / — | U-3341 | — | openFDA ↗ |
| N211675-002 | 11661425 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | 11680069 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | 11718627 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | 11767326 | 2036/10/17 | — / — | U-3298 | — | openFDA ↗ |
| N211675-002 | 11773105 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | 12077545 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 12091415 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 12110298 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | 12116373 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-002 | 8962629 | 2031/01/15 | Y / — | U-3624 | — | openFDA ↗ |
| N211675-002 | 9951080 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-002 | RE47221 | 2033/08/16 | Y / — | — | — | openFDA ↗ |
| N211675-003 | 10202393 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-003 | 10981923 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-003 | 11186584 | 2036/10/17 | Y / — | — | — | openFDA ↗ |
| N211675-003 | 11198697 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-003 | 11564922 | 2038/03/09 | — / — | U-4303 | — | openFDA ↗ |
| N211675-003 | 11607411 | 2038/03/09 | — / — | U-3341 | — | openFDA ↗ |
| N211675-003 | 11661425 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | 11680069 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | 11718627 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | 11773105 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | 12077545 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-003 | 12110298 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | 12134621 | 2036/10/17 | — / Y | — | — | openFDA ↗ |
| N211675-003 | 8962629 | 2031/01/15 | Y / — | U-3624 | — | openFDA ↗ |
| N211675-003 | 9951080 | 2036/10/17 | Y / Y | — | — | openFDA ↗ |
| N211675-003 | RE47221 | 2033/08/16 | Y / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2032/04/28
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N211675-001 | I-919 | 2026/05/18 | openFDA ↗ |
| N211675-001 | I-946 | 2027/04/26 | openFDA ↗ |
| N211675-001 | I-966 | 2028/04/28 | openFDA ↗ |
| N211675-001 | NPP | 2027/04/26 | openFDA ↗ |
| N211675-001 | ODE-481 | 2031/04/26 | openFDA ↗ |
| N211675-001 | ODE-538 | 2032/04/28 | openFDA ↗ |
| N211675-002 | I-919 | 2026/05/18 | openFDA ↗ |
| N211675-002 | I-946 | 2027/04/26 | openFDA ↗ |
| N211675-002 | NPP | 2027/04/26 | openFDA ↗ |
| N211675-002 | ODE-481 | 2031/04/26 | openFDA ↗ |
| N211675-003 | I-919 | 2026/05/18 | openFDA ↗ |
| N211675-003 | I-946 | 2027/04/26 | openFDA ↗ |
| N211675-003 | NPP | 2027/04/26 | openFDA ↗ |
| N211675-003 | ODE-481 | 2031/04/26 | 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 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20265705See source | 2026/08/25 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20265479See source | 2026/08/04 | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20265230See source | 2026/07/21 | Official source ↗ |
| Shanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanized | 国药准字H20265099See source | 2026/07/08 | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20264996See source | 2026/06/30 | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H20264361See source | 2026/05/19 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20264176See source | 2026/04/29 | Official source ↗ |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20264136See source | 2026/04/21 | Official source ↗ |
NHSA approval numbers 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220010See source | — | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220010See source | — | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220011See source | — | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220011See source | — | Official source ↗ |
| Abbvie Deutschland GmbH&Co.KG | 国药准字HJ20233125See source | — | Official source ↗ |
| Abbvie Deutschland GmbH&Co.KG | 国药准字HJ20233125See source | — | Official source ↗ |
Under review 43
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600342 | 2026/02/03 | Official source ↗ |
| Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2601493 | 2026/06/25 | Official source ↗ |
| Qilu Pharmaceutical (Hainan) Co., Ltd | CYHS2504442 | 2025/12/26 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2504513 | 2025/12/31 | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2504433 | 2025/12/26 | Official source ↗ |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | CYHS2501221 | 2025/03/28 | Official source ↗ |
| Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | CYHS2600962 | 2026/04/25 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | CYHS2600004 | 2026/01/04 | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | CYHS2502604 | 2025/07/19 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2602299 | 2026/09/16 | Official source ↗ |
| AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. | JXHL2600400 | 2026/09/11 | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. | JXHS2600101 | 2026/08/25 | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. | JXHS2600100 | 2026/08/24 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2601947 | 2026/08/10 | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600184 | 2026/07/31 | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600183 | 2026/07/31 | Official source ↗ |
| AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600182 | 2026/07/31 | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | CYHS2601776 | 2026/07/24 | Official source ↗ |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHS2601416 | 2026/06/15 | Official source ↗ |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | CYHS2601404 | 2026/06/12 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanized | CYHS2601186 | 2026/05/20 | Official source ↗ |
| Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2601096 | 2026/05/13 | Official source ↗ |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2601095 | 2026/05/13 | Official source ↗ |
| Shandong Yu Xin Pharma Co., Ltd. romanized | CYHS2600807 | 2026/04/09 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2600226 | 2026/01/20 | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600063 | 2026/01/07 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2504480 | 2025/12/30 | Official source ↗ |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized | CYHS2504441 | 2025/12/27 | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | CYHS2504368 | 2025/12/24 | Official source ↗ |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | CYHS2504198 | 2025/12/06 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2504028 | 2025/11/21 | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | CYHS2503365 | 2025/09/11 | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2503067 | 2025/08/21 | Official source ↗ |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized | CYHS2502795 | 2025/08/02 | Official source ↗ |
| Guangzhou Yu Dong Health Pharmaceutical Co., Ltd. romanized | CYHS2502579 | 2025/07/18 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | CYHS2502203 | 2025/06/19 | Official source ↗ |
| Beijing Bei Lu Pharma Co., Ltd. romanized; Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2502132 | 2025/06/14 | Official source ↗ |
| Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2502111 | 2025/06/12 | Official source ↗ |
| Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized | CYHS2403496 | 2024/10/16 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | CYHS2400271 | 2024/01/19 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | CYHS2400083 | 2024/01/06 | Official source ↗ |
| Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized | CYHS2602622 | 2026/10/26 | Official source ↗ |
| Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | CYHS2602676 | 2026/11/02 | Official source ↗ |
Generic-filing companies this year 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600342 | 2026/02/03 | Official source ↗ |
| Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2601493 | 2026/06/25 | Official source ↗ |
| Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | CYHS2600962 | 2026/04/25 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | CYHS2600004 | 2026/01/04 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2602299 | 2026/09/16 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2601947 | 2026/08/10 | Official source ↗ |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | CYHS2601920 | 2026/08/06 | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | CYHS2601776 | 2026/07/24 | Official source ↗ |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHS2601416 | 2026/06/15 | Official source ↗ |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | CYHS2601404 | 2026/06/12 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceutical Co., Ltd. romanized | CYHS2601186 | 2026/05/20 | Official source ↗ |
| Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2601096 | 2026/05/13 | Official source ↗ |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2601095 | 2026/05/13 | Official source ↗ |
| Shandong Yu Xin Pharma Co., Ltd. romanized | CYHS2600807 | 2026/04/09 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2600226 | 2026/01/20 | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600063 | 2026/01/07 | Official source ↗ |
| Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized | CYHS2602622 | 2026/10/26 | Official source ↗ |
| Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | CYHS2602676 | 2026/11/02 | Official source ↗ |
API companies with A status 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20250000199 | 2026/10/21 | Official source ↗ |
| Hubei Tian Shu Pharma Co., Ltd. romanized | Y20250000234 | 2026/09/29 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20250000068 | 2026/11/11 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20240001377 | 2026/11/08 | Official source ↗ |
| Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240001538 | 2026/06/11 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20240001316 | 2026/06/23 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240001109 | 2026/08/12 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20240000970 | 2026/04/03 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Y20230001341 | 2025/03/19 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20230000796 | 2026/06/23 | 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
- CDE chemical-drug catalogue detail ↗ · idCode=381b244ecabeac0e48effcf5c090a1ac
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy