Application 050731
- Type
- NDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9550 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride | West-Ward Pharmaceuticals Corp | NDA | Current |
| 0143-9550 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9551 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride | West-Ward Pharmaceuticals Corp | NDA | Current |
| 0143-9551 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55762 | SUPPL | 2018-10-01 |
| 22211 | ORIG | 1998-01-30 |