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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Chinese Patent Office
Fuji
Johnson and Johnson
QuintilesIMS
Moodys
McKesson
US Army
Citi

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075819

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NDA 075819 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 075819
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Cmp Pharma Inc
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075819
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 075819
Suppliers and Packaging for NDA: 075819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075819 ANDA CMP Pharma, Inc. 46287-015 E 46287-015-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Sep 11, 2002TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Daiichi Sankyo
Farmers Insurance
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McKesson
Dow
Federal Trade Commission
Chubb

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