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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208278

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NDA 208278 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 208278

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 208278

Mechanism of ActionM2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 208278

Suppliers and Packaging for NDA: 208278

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 208278 ANDA Major Pharmaceuticals 0904-6630 0904-6630-61 100 BLISTER PACK in 1 CARTON (0904-6630-61) > 1 CAPSULE in 1 BLISTER PACK
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 208278 ANDA Cadila Healthcare Limited 65841-835 65841-835-05 500 CAPSULE in 1 BOTTLE (65841-835-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 31, 2016TE:ABRLD:No


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