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Serving leading biopharmaceutical companies globally:

Novartis
QuintilesIMS
Daiichi Sankyo
Mallinckrodt
Fish and Richardson
Fuji
Federal Trade Commission
Julphar
Chubb
Healthtrust

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071293

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NDA 071293 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Lannett Holdings Inc, Newgen Pharms Llc, Sandoz, Strides Pharma, Usl Pharma, Watson Labs, Watson Labs Inc, Zydus Pharms Usa Inc, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Silarx, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics, and is included in twenty-six NDAs. It is available from forty-two suppliers. Additional details are available on the AMANTADINE HYDROCHLORIDE profile page.

The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 071293
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 071293
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 071293
Suppliers and Packaging for NDA: 071293
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 071293 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-0326 N 0615-0326-39
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 071293 ANDA Sandoz Inc 0781-2048 N 0781-2048-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 18, 1987TE:ABRLD:No

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