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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075060

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NDA 075060 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 075060
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Wockhardt Bio Ag
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075060
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 075060
Suppliers and Packaging for NDA: 075060
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075060 ANDA Atlantic Biologicals Corps 17856-0093 N 17856-0093-3
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075060 ANDA Physicians Total Care, Inc. 54868-3216 E 54868-3216-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Dec 24, 1998TE:AARLD:No

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