Application 065035
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-5233 | daunorubicin hydrochloride | daunorubicin hydrochloride | Teva Parenteral Medicines, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 8376 | ORIG | 2000-01-24 |