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Details for New Drug Application (NDA): 208278

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NDA 208278 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: 208278

Tradename:
AMANTADINE HYDROCHLORIDE
Applicant:
Zydus Pharms Usa Inc
Ingredient:
amantadine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 208278

Mechanism of ActionM2 Protein Inhibitors

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 Cadila Healthcare Limited 65841-835 65841-835-01 100 CAPSULE in 1 BOTTLE (65841-835-01)
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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