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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Fuji
Healthtrust
Citi
Federal Trade Commission
McKesson
Accenture
Farmers Insurance
Daiichi Sankyo

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074170

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NDA 074170 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, and Wockhardt, and is included in twenty-five 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 074170
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Hi Tech Pharma
Ingredient:amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 074170
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 074170
Suppliers and Packaging for NDA: 074170
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074170 ANDA Hi-Tech Pharmacal Co., Inc. 50383-807 50383-807-16 473 mL in 1 BOTTLE (50383-807-16)
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074170 ANDA Hi-Tech Pharmacal Co., Inc. 50383-807 50383-807-12 10 TRAY in 1 CASE (50383-807-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-807-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Oct 28, 1994TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
Harvard Business School
QuintilesIMS
Farmers Insurance
McKesson
Deloitte
Fish and Richardson
Accenture

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