Details for New Drug Application (NDA): 074672
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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 074672
Tradename: | SELEGILINE HYDROCHLORIDE |
Applicant: | Mlv |
Ingredient: | selegiline hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 074672
Mechanism of Action | Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors |
Suppliers and Packaging for NDA: 074672
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074672 | ANDA | i3 Pharmaceuticals, LLC | 72319-006 | 72319-006-02 | 60 TABLET in 1 BOTTLE (72319-006-02) |
SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | TABLET;ORAL | 074672 | ANDA | A2A Integrated Pharmaceuticals | 73141-006 | 73141-006-02 | 60 TABLET in 1 BOTTLE (73141-006-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 1, 1997 | TE: | AB | RLD: | No |
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