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Last Updated: February 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206803

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NDA 206803 describes SELEGILINE HYDROCHLORIDE, which is a drug marketed by Apotex, Dava Pharms Inc, Lannett Co Inc, Rising, Acp Nimble, Allied, Apotex Inc, Boscogen, Chartwell Molecules, G And W Labs Inc, 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 206803
Ingredient:selegiline hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 206803
Suppliers and Packaging for NDA: 206803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELEGILINE HYDROCHLORIDE selegiline hydrochloride CAPSULE;ORAL 206803 ANDA Rising Pharmaceuticals, Inc. 16571-659 16571-659-06 60 CAPSULE in 1 BOTTLE (16571-659-06)
SELEGILINE HYDROCHLORIDE selegiline hydrochloride CAPSULE;ORAL 206803 ANDA Rising Pharmaceuticals, Inc. 16571-659 16571-659-50 500 CAPSULE in 1 BOTTLE (16571-659-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Apr 2, 2019TE:ABRLD:No

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