Details for New Drug Application (NDA): 075321
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NDA 075321 describes SELEGILINE HYDROCHLORIDE, which is a drug marketed by Apotex, Lannett Co Inc, Novitium Pharma, Rising, Apotex Inc, Chartwell Molecules, Cosette, Dash Pharms Natco, G And W Labs Inc, I3 Pharms, Kenton, and Norvium Bioscience, and is included in fourteen NDAs. It is available from ten suppliers. Additional details are available on the SELEGILINE HYDROCHLORIDE profile page.
The generic ingredient in SELEGILINE HYDROCHLORIDE is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.
The generic ingredient in SELEGILINE HYDROCHLORIDE is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.
Summary for 075321
| Tradename: | SELEGILINE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | selegiline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075321
| Mechanism of Action | Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors |
Suppliers and Packaging for NDA: 075321
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | CAPSULE;ORAL | 075321 | ANDA | Apotex Corp. | 60505-0055 | 60505-0055-1 | 60 CAPSULE in 1 BOTTLE (60505-0055-1) |
| SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | CAPSULE;ORAL | 075321 | ANDA | Apotex Corp. | 60505-0055 | 60505-0055-2 | 1000 CAPSULE in 1 BOTTLE (60505-0055-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 4, 1998 | TE: | AB | RLD: | No | ||||
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