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Application 020207
- Type
- NDA
- Sponsor
- APOTEX
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALKERAN | MELPHALAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52609-3001 | ALKERAN | melphalan hydrochloride | ApoPharma USA, Inc. | NDA | Current |
| 52609-3001 | ALKERAN | melphalan hydrochloride | ApoPharma USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 34367 | SUPPL | 2011-06-14 |
| 24575 | SUPPL | 2011-06-14 |
| 24576 | SUPPL | 2011-05-04 |
| 34368 | SUPPL | 2011-05-02 |
| 24574 | SUPPL | 2005-06-15 |
| 12318 | SUPPL | 2004-02-06 |
| 24573 | SUPPL | 2003-05-29 |
| 2167 | SUPPL | 2002-01-07 |