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Matched- Active ingredients (original)
- ONDANSETRON HYDROCHLORIDE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
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 approval1991/01/04
ANDA applications48
RLD applicantGLAXOSMITHKLINE / SANDOZ INC
Currently marketed products: 18 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076695-001 | ONDANSETRON HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076696-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076759-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | TEVA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/11/22 | N / N | DISCONTINUED | openFDA ↗ |
| A076780-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | HIKMA FARMACEUTICA (PORTUGAL) SA | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076781-001 | ONDANSETRON HYDROCHLORIDE | HIKMA FARMACEUTICA (PORTUGAL) SA | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076876-001 | ONDANSETRON HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/11/22 | N / N | DISCONTINUED | openFDA ↗ |
| A076967-001 | ONDANSETRON HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076972-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076974-001 | ONDANSETRON HYDROCHLORIDE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076978-001 | ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 0.64MG BASE/ML | 2007/02/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077011-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077172-001 | ONDANSETRON HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077173-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | SUN PHARMACEUTICAL INDUSTRIES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077343-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | APOTEX INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077365-001 | ONDANSETRON HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077368-001 | ONDANSETRON HYDROCHLORIDE | APOTEX INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077387-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | AMERICAN REGENT INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077430-001 | ONDANSETRON HYDROCHLORIDE | SANDOZ INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2007/06/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077473-001 | ONDANSETRON HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077541-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077544-001 | ONDANSETRON HYDROCHLORIDE | PLIVA HRVATSKA DOO | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077548-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077551-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | SANDOZ INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2007/06/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077577-001 | ONDANSETRON HYDROCHLORIDE | WOCKHARDT BIO AG | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077582-001 | ONDANSETRON HYDROCHLORIDE | AMERICAN REGENT INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A077716-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | WOCKHARDT BIO AG | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077840-001 | ONDANSETRON HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2007/01/19 | N / N | DISCONTINUED | openFDA ↗ |
| A078014-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | TARO PHARMACEUTICALS IRELAND LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2008/03/21 | N / N | DISCONTINUED | openFDA ↗ |
| A078180-001 | ONDANSETRON HYDROCHLORIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2007/03/26 | N / N | DISCONTINUED | openFDA ↗ |
| A078244-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONESOURCE SPECIALTY PTE LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2008/04/23 | N / N | DISCONTINUED | openFDA ↗ |
| A078257-001 | ONDANSETRON HYDROCHLORIDE | ONESOURCE SPECIALTY PTE LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2008/04/23 | N / N | DISCONTINUED | openFDA ↗ |
| A078287-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2013/02/22 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078288-001 | ONDANSETRON HYDROCHLORIDE | BAXTER HEALTHCARE CORP | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2013/02/22 | N / N | DISCONTINUED | openFDA ↗ |
| A078945-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2013/01/03 | N / N | DISCONTINUED | openFDA ↗ |
| A079032-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | AMERICAN REGENT INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2008/11/18 | N / N | DISCONTINUED | openFDA ↗ |
| A079039-001 | ONDANSETRON HYDROCHLORIDE | LUITPOLD PHARMACEUTICALS INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2008/11/18 | N / N | DISCONTINUED | openFDA ↗ |
| A079224-001 | ONDANSETRON HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2009/09/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090116-001 | ONDANSETRON HYDROCHLORIDE | CHARTWELL MOLECULAR HOLDINGS LLC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2010/04/14 | N / N | DISCONTINUED | openFDA ↗ |
| A090424-001 | ONDANSETRON HYDROCHLORIDE | AVET LIFESCIENCES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2010/04/16 | N / N | DISCONTINUED | openFDA ↗ |
| A090648-001 | ONDANSETRON HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2012/06/15 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090883-001 | ONDANSETRON HYDROCHLORIDE | LANNETT CO INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2010/08/05 | N / N | DISCONTINUED | openFDA ↗ |
| A202253-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2013/07/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202599-001 | ONDANSETRON HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2012/12/21 | N / N | DISCONTINUED | openFDA ↗ |
| A202600-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2012/12/21 | N / N | DISCONTINUED | openFDA ↗ |
| A203711-001 | ONDANSETRON HYDROCHLORIDE | QILU PHARMACEUTICAL HAINAN CO LTD | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2014/09/08 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204906-001 | ONDANSETRON HYDROCHLORIDE | RISING PHARMA HOLDING INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2017/07/31 | N / N | DISCONTINUED | openFDA ↗ |
| A206845-001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ACCORD HEALTHCARE INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2016/03/10 | N / N | DISCONTINUED | openFDA ↗ |
| A206846-001 | ONDANSETRON HYDROCHLORIDE | ACCORD HEALTHCARE INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML | 2015/07/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020007-001 | ZOFRAN | SANDOZ INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1991/01/04 | Y / N | DISCONTINUED | openFDA ↗ |
| N020007-003 | ZOFRAN PRESERVATIVE FREE | SANDOZ INC | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1993/12/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N020403-001 | ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | GLAXOSMITHKLINE | INJECTABLE | INJECTION | ONDANSETRON HYDROCHLORIDE: EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1995/01/31 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
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 |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
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 |
|---|---|---|---|
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20054704See source | 2026/04/16 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067242See source | 2025/09/22 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067241See source | 2025/09/22 | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20045984See source | 2024/07/17 | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20083759See source | 2024/07/17 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243751See source | 2024/05/21 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243750See source | 2024/05/21 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059359See source | 2021/10/15 | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213744See source | 2021/09/24 | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213743See source | 2021/09/24 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960148See source | 2021/06/16 | Official source ↗ |
| Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20093182See source | 2021/01/28 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970064See source | 2021/01/27 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970065See source | 2021/01/27 | Official source ↗ |
NHSA approval numbers 51
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213743See source | — | Official source ↗ |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H200664742ml:4mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970179See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055086See source | — | Official source ↗ |
| Liaoning Tian Long Pharma Co., Ltd. romanized | 国药准字H20056409See source | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H200464932ml:4mg | — | Official source ↗ |
| Chengdu Ping Yuan Pharma Co., Ltd. romanized | 国药准字H20059328See source | — | Official source ↗ |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H20046058See source | — | Official source ↗ |
| Chengdu Ping Yuan Pharma Co., Ltd. romanized | 国药准字H20059329See source | — | Official source ↗ |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | 国药准字H20053255See source | — | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20045984See source | — | Official source ↗ |
| Shaanxi Kai Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20065286See source | — | Official source ↗ |
| Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | 国药准字H20059084See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243750See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20059317See source | — | Official source ↗ |
| Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20053855See source | — | Official source ↗ |
| Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized | 国药准字H20054309See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059290See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20054696See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970065See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20073245See source | — | Official source ↗ |
| Shandong Feng Huang Pharmaceutical Co., Ltd. romanized | 国药准字H20055769See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067241See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20054704See source | — | Official source ↗ |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H20054892See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20063029See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960149See source | — | Official source ↗ |
| Jiangxi Run Ze Pharma Co., Ltd. romanized | 国药准字H20067340See source | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H200931712ml:4mg | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20093182See source | — | Official source ↗ |
| Novartis Pharma Schweiz AG | H201703154ml:8mg | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213743See source | — | Official source ↗ |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H200664742ml:4mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970179See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055086See source | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H200464932ml:4mg | — | Official source ↗ |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H20046058See source | — | Official source ↗ |
| Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | 国药准字H20059084See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243750See source | — | Official source ↗ |
| Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20053855See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059290See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20054696See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970065See source | — | Official source ↗ |
| Shandong Feng Huang Pharmaceutical Co., Ltd. romanized | 国药准字H20055769See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067241See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20054704See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20063029See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960149See source | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H200931712ml:4mg | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20093182See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067241See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067241See source | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213744See source | — | Official source ↗ |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H200664754ml:8mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970180See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055087See source | — | Official source ↗ |
| Chengdu Li Er Pharma Co., Ltd. romanized | 国药准字H20046059See source | — | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20083759See source | — | Official source ↗ |
| Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | 国药准字H20059083See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243751See source | — | Official source ↗ |
| Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20053856See source | — | Official source ↗ |
| Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized | 国药准字H20054310See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059359See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20054697See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970064See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20073245See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067242See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20063028See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960148See source | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H200931724ml:8mg | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20093183See source | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213744See source | — | Official source ↗ |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H200664754ml:8mg | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970180See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055087See source | — | Official source ↗ |
| Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | 国药准字H20059083See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20243751See source | — | Official source ↗ |
| Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20053856See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059359See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20054697See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970064See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067242See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20063028See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960148See source | — | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H200931724ml:8mg | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20093183See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059359See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067242See source | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20059359See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20067242See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055086See source | — | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20083759See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20063167See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055086See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20063167See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055087See source | — | Official source ↗ |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20045984See source | — | Official source ↗ |
| Chongqing Lai Mei Pharma Co., Ltd. romanized | 国药准字H20055087See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20063166See source | — | Official source ↗ |
| Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20063166See source | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2601824 | 2026/07/29 | Official source ↗ |
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2601823 | 2026/07/29 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHB2650013 | 2026/01/13 | Official source ↗ |
| Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized | CYHS2504236 | 2025/12/10 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | CYHS2602687 | 2026/11/03 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2601824 | 2026/07/29 | Official source ↗ |
| Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized | CYHS2601823 | 2026/07/29 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | CYHS2602687 | 2026/11/03 | Official source ↗ |
API companies with A status 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20250000593 | 2026/10/16 | Official source ↗ |
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20230000303 | 2026/06/16 | Official source ↗ |
| Dr. Reddy's Laboratories Ltd. | Y20220001178 | 2025/08/28 | Official source ↗ |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20220000619 | 2025/05/09 | Official source ↗ |
| Apitoria Pharma Private Limited | Y20210000190 | 2025/07/15 | Official source ↗ |
| Natco Pharma Limited | Y20200000836 | 2024/01/31 | Official source ↗ |
| Dr. Reddy's Laboratories Ltd. | Y20200000931 | 2026/05/20 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190021613 | 2026/08/20 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Y20190009491 | — | Official source ↗ |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | Y20190006261 | — | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | Y20190006208 | 2024/06/28 | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190004948 | 2025/08/30 | Official source ↗ |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190003744 | 2025/07/18 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | Y20190002237 | 2025/09/01 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20190001571 | 2024/11/21 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20180001049 | 2025/07/18 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Y20170002166 | 2025/01/25 | 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.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 21-28 · 2019/08/06
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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