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Express Scripts
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Colorcon
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074509

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NDA 074509 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Lannett Co 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, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics, and is included in twenty-six NDAs. It is available from forty-three 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-four suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 074509
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Pharm Assoc
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 074509
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 074509
Suppliers and Packaging for NDA: 074509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074509 ANDA Pharmaceutical Associates, Inc. 0121-0646 N 0121-0646-10
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074509 ANDA Pharmaceutical Associates, Inc. 0121-0646 N 0121-0646-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Jul 17, 1995TE:AARLD:No

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