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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074871

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NDA 074871 describes SELEGILINE HYDROCHLORIDE, which is a drug marketed by Apotex, Dava Pharms Inc, Lannett Co Inc, Rising, Acp Nimble, Apotex Inc, Boscogen, Chartwell Molecules, G And W Labs Inc, MLV, Mylan, and Somerset, and is included in fourteen NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.
Summary for 074871
Applicant:Apotex Inc
Ingredient:selegiline hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 074871
Suppliers and Packaging for NDA: 074871
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 074871 ANDA Golden State Medical Supply, Inc. 60429-176 60429-176-60 60 TABLET in 1 BOTTLE (60429-176-60)
SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 074871 ANDA Apotex Corp. 60505-3438 60505-3438-3 60 TABLET in 1 BOTTLE (60505-3438-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 6, 1997TE:ABRLD:No

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