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Generated: April 25, 2017

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Details for New Drug Application (NDA): 071293

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NDA 071293 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Watson Labs Inc, Pharm Assoc, Teva Pharms, Carolina Medcl, Bionpharma Inc, Mikart, Silarx, G And W Labs Inc, Actavis Elizabeth, Wockhardt, Newgen Pharms Llc, Hi Tech Pharma, Zydus Pharms Usa Inc, Watson Labs, Usl Pharma, Vintage, and Sandoz, and is included in twenty 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-seven suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for NDA: 071293

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

Pharmacology for NDA: 071293

Mechanism of ActionM2 Protein Inhibitors

Suppliers and Packaging for NDA: 071293

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL 071293 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-0326 0615-0326-39 30 CAPSULE in 1 BLISTER PACK (0615-0326-39)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL 071293 ANDA Sandoz Inc 0781-2048 0781-2048-01 100 CAPSULE in 1 BOTTLE (0781-2048-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 18, 1987TE:ABRLD:No


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