Details for New Drug Application (NDA): 076186
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The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 076186
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Upsher Smith Labs |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076186
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 076186
Suppliers and Packaging for NDA: 076186
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 076186 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0111 | 0832-0111-00 | 100 TABLET in 1 BOTTLE (0832-0111-00) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 076186 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0111 | 0832-0111-03 | 100 BLISTER PACK in 1 CARTON (0832-0111-03) / 1 TABLET in 1 BLISTER PACK (0832-0111-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 16, 2002 | TE: | AB | RLD: | No |
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