Details for New Drug Application (NDA): 021479
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The generic ingredient in ZELAPAR 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 021479
Tradename: | ZELAPAR |
Applicant: | Bausch |
Ingredient: | selegiline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021479
Mechanism of Action | Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors |
Suppliers and Packaging for NDA: 021479
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479 | NDA | Bausch Health US, LLC | 0187-0453 | 0187-0453-02 | 6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1.25MG | ||||
Approval Date: | Jun 14, 2006 | TE: | RLD: | Yes |
Expired US Patents for NDA 021479
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479-001 | Jun 14, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479-001 | Jun 14, 2006 | ⤷ Sign Up | ⤷ Sign Up |
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