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Chinese Patent Office
McKinsey
US Department of Justice
Healthtrust
Express Scripts
Fish and Richardson
QuintilesIMS
Deloitte
Queensland Health

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078720

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NDA 078720 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 thirty-seven 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 078720
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Bionpharma Inc
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078720
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 078720
Suppliers and Packaging for NDA: 078720
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 078720 ANDA Lannett Company, Inc. 0527-1704 N 0527-1704-05
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 078720 ANDA Lannett Company, Inc. 0527-1704 N 0527-1704-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 29, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Moodys
Dow
Teva
Baxter
Julphar
Cipla
Colorcon

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