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Application 065339
- Type
- ANDA
- Sponsor
- EBEWE PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No |
| 002 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 66758-042 | Epirubicin Hydrochloride | Epirubicin Hydrochloride | Sandoz Inc | ANDA | Current |