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Details for New Drug Application (NDA): 074170

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NDA 074170 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by 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 seventeen NDAs. It is available from thirty-three 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-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for NDA: 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

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 50383-807-12 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)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Oct 28, 1994TE:AARLD:Yes


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