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Harvard Business School
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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076186

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NDA 076186 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 076186
Applicant:Usl Pharma
Ingredient:amantadine hydrochloride
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076186
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 076186
Suppliers and Packaging for NDA: 076186
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 076186 ANDA Upsher-Smith Laboratories, LLC 0832-0111 N 0832-0111-03
AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 076186 ANDA Upsher-Smith Laboratories, LLC 0832-0111 N 0832-0111-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 16, 2002TE:ABRLD:No

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