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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210129

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NDA 210129 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Lannett Co Inc, Novelgenix Theraps, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Akorn, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics, and is included in thirty-one NDAs. It is available from twenty-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. Twenty-nine suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 210129
Applicant:Novelgenix Theraps
Ingredient:amantadine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 210129
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 210129
Suppliers and Packaging for NDA: 210129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 210129 ANDA Marlex Pharmaceuticals Inc 10135-693 10135-693-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-01)
AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 210129 ANDA Marlex Pharmaceuticals Inc 10135-693 10135-693-05 500 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 2, 2020TE:ABRLD:No

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