Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021479

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NDA 021479 describes ZELAPAR, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the ZELAPAR profile page.

The generic ingredient in ZELAPAR is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Six 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
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 Valeant Pharmaceuticals North America 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:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1.25MG
Approval Date:Jun 14, 2006TE: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   Start Trial   Start Trial
Bausch ZELAPAR selegiline hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021479-001 Jun 14, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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