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Application 014691
- Type
- NDA
- Sponsor
- APOTEX
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | ALKERAN | MELPHALAN | TABLET;ORAL | 2MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52609-0001 | ALKERAN | melphalan | ApoPharma USA, Inc. | NDA | Current |
| 52609-0001 | ALKERAN | melphalan | ApoPharma USA, Inc. | NDA | Current |
| 52609-0001 | ALKERAN | melphalan | ApoPharma USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 33124 | SUPPL | 2011-06-14 |
| 12071 | SUPPL | 2011-06-14 |
| 383 | SUPPL | 2011-05-04 |
| 10848 | SUPPL | 2011-05-02 |
| 382 | SUPPL | 2005-06-14 |
| 40695 | SUPPL | 2003-07-05 |
| 12070 | SUPPL | 2003-06-08 |
| 10847 | SUPPL | 2003-05-28 |
| 381 | SUPPL | 2002-01-07 |
| 380 | SUPPL | 2001-05-24 |