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Serving leading biopharmaceutical companies globally:

Julphar
AstraZeneca
Mallinckrodt
Federal Trade Commission
Cipla
McKinsey
Healthtrust
Chinese Patent Office
QuintilesIMS
Farmers Insurance

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021479

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NDA 021479 describes ZELAPAR, which is a drug marketed by Valeant Pharm Intl 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. Nine suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.
Summary for 021479
Tradename:ZELAPAR
Applicant:Valeant Pharm Intl
Ingredient:selegiline hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
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 N 0187-0453-03
ZELAPAR selegiline hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021479 NDA Valeant Pharmaceuticals North America LLC 0187-0453 N 0187-0453-02

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
Valeant Pharm Intl ZELAPAR selegiline hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021479-001 Jun 14, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharm Intl ZELAPAR selegiline hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021479-001 Jun 14, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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