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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 071293


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NDA 071293 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Rising, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, G And W Labs Inc, Genus, Pharm Assoc, Teva Pharms, Vintage, Xttrium Labs Inc, Athem, Edenbridge Pharms, and Jubilant Generics, and is included in thirty-four NDAs. It is available from thirty 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-one suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 071293
Tradename:AMANTADINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:amantadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 071293

Profile for product number 001

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

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