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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
US Army
Chinese Patent Office
Federal Trade Commission

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070589

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NDA 070589 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Watson Labs Inc, Pharm Assoc, Teva Pharms, Cmp Pharma Inc, Bionpharma Inc, Lannett Holdings Inc, Mikart, Strides Pharma, Silarx, G And W Labs Inc, Actavis Elizabeth, Wockhardt, Newgen Pharms Llc, Hi Tech Pharma, Heritage Pharma, Zydus Pharms Usa Inc, Watson Labs, Usl Pharma, Vintage, and Sandoz, and is included in twenty-four NDAs. It is available from thirty-nine 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-nine suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for NDA: 070589

Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070589

Mechanism of ActionM2 Protein Inhibitors

Suppliers and Packaging for NDA: 070589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amantadine hydrochloride
CAPSULE;ORAL 070589 ANDA Upsher-Smith Laboratories, Inc 0832-1015 0832-1015-00 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00)
amantadine hydrochloride
CAPSULE;ORAL 070589 ANDA Upsher-Smith Laboratories, Inc 0832-1015 0832-1015-50 500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 5, 1986TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Queensland Health
Fish and Richardson
US Department of Justice
Chinese Patent Office

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