Application 207252
- Type
- ANDA
- Sponsor
- JIANGSU HENGRUI MED
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 25021-245 | Docetaxel | Docetaxel Anhydrous | Sagent Pharmaceuticals | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3041 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3042 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Medicine Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
| 57884-3043 | Docetaxel | Docetaxel | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49688 | ORIG | 2017-09-07 |