Details for New Drug Application (NDA): 210215
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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 210215
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Athem |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210215
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 210215
Suppliers and Packaging for NDA: 210215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 210215 | ANDA | Marlex Pharmaceuticals Inc | 10135-692 | 10135-692-01 | 100 TABLET in 1 BOTTLE (10135-692-01) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 210215 | ANDA | Marlex Pharmaceuticals Inc | 10135-692 | 10135-692-05 | 500 TABLET in 1 BOTTLE (10135-692-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 10, 2020 | TE: | AB | RLD: | No |
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