Application 204490
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9204 | Docetaxel | Docetaxel | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9204 | Docetaxel | Docetaxel | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9205 | Docetaxel | Docetaxel | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9205 | Docetaxel | Docetaxel | Hikma Pharmaceuticals USA Inc. | ANDA | Current |