Application 076871
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| 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 | Yes |
| 002 | MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | No | Yes |
| 003 | MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61703-343 | Mitoxantrone | Mitoxantrone | Hospira, Inc. | ANDA | Current |
| 61703-343 | Mitoxantrone | Mitoxantrone | Hospira, Inc. | ANDA | Current |
| 61703-343 | Mitoxantrone | Mitoxantrone | Hospira, Inc. | ANDA | Current |
| 61703-343 | Mitoxantrone | Mitoxantrone | Hospira, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8973 | ORIG | 2006-04-13 |