Details for New Drug Application (NDA): 214284
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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 214284
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214284
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 214284
Suppliers and Packaging for NDA: 214284
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 214284 | ANDA | Alembic Pharmaceuticals Limited | 46708-586 | 46708-586-31 | 100 TABLET in 1 BOTTLE (46708-586-31) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 214284 | ANDA | Alembic Pharmaceuticals Limited | 46708-586 | 46708-586-71 | 500 TABLET in 1 BOTTLE (46708-586-71) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 15, 2020 | TE: | AB | RLD: | No |
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