Details for New Drug Application (NDA): 014691
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NDA 014691 describes ALKERAN, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. Additional details are available on the ALKERAN profile page.
The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the melphalan profile page.
The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the melphalan profile page.
Summary for 014691
| Tradename: | ALKERAN |
| Applicant: | Apotex |
| Ingredient: | melphalan |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 014691
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 014691
Suppliers and Packaging for NDA: 014691
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALKERAN | melphalan | TABLET;ORAL | 014691 | NDA | ApoPharma USA, Inc. | 52609-0001 | 52609-0001-5 | 50 TABLET, FILM COATED in 1 BOTTLE (52609-0001-5) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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