Application 065440
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 002 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/10ML (1MG/ML) | No | No |
| 003 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 20MG/20ML (1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-194 | Idarubicin Hydrochloride | IDARUBICIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |