Application 210327
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
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 |
|---|
| 72485-214 | Docetaxel | Docetaxel | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-215 | Docetaxel | Docetaxel | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-216 | Docetaxel | Docetaxel | Armas Pharmaceuticals Inc. | ANDA | Current |