| Product NDC: | 52609-3001 |
| Proprietary Name: | ALKERAN |
| Non Proprietary Name: | melphalan hydrochloride |
| Active Ingredient(s): | & nbsp; melphalan hydrochloride |
| Administration Route(s): | |
| Dosage Form(s): | KIT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52609-3001 |
| Labeler Name: | Apo-Pharma USA, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020207 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110101 |
| Package NDC: | 52609-3001-0 |
| Package Description: | 1 KIT in 1 CARTON (52609-3001-0) * 10 mL in 1 VIAL, SINGLE-DOSE (52609-3002-0) * 10 mL in 1 VIAL, SINGLE-USE (52609-3003-0) |
| NDC Code | 52609-3001-0 |
| Proprietary Name | ALKERAN |
| Package Description | 1 KIT in 1 CARTON (52609-3001-0) * 10 mL in 1 VIAL, SINGLE-DOSE (52609-3002-0) * 10 mL in 1 VIAL, SINGLE-USE (52609-3003-0) |
| Product NDC | 52609-3001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | melphalan hydrochloride |
| Dosage Form Name | KIT |
| Route Name | |
| Start Marketing Date | 20110101 |
| Marketing Category Name | NDA |
| Labeler Name | Apo-Pharma USA, Inc |
| Substance Name | |
| Strength Number | |
| Strength Unit | |
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