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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
Healthtrust
Chubb
Express Scripts
Daiichi Sankyo
Cipla
AstraZeneca
Fish and Richardson
Deloitte

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207570

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NDA 207570 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 207570
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Newgen Pharms Llc
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 207570
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 207570
Suppliers and Packaging for NDA: 207570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 207570 ANDA NewGen Pharmaceuticals LLC 68996-102 N 68996-102-50
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 207570 ANDA NewGen Pharmaceuticals LLC 68996-102 N 68996-102-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 30, 2016TE:ABRLD:No

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Citi
Baxter
Johnson and Johnson
McKinsey
US Army
UBS
US Department of Justice
AstraZeneca
Moodys

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