Application 077496
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | No | No |
| 002 | MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | No | No |
| 003 | MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-132 | Mitoxantrone | MITOXANTRONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-132 | Mitoxantrone | MITOXANTRONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31250 | ORIG | 2006-04-13 |