Details for New Drug Application (NDA): 078720
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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 078720
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Bionpharma |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078720
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 078720
Suppliers and Packaging for NDA: 078720
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 078720 | ANDA | AvKARE | 42291-125 | 42291-125-50 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-125-50) |
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 078720 | ANDA | AvPAK | 50268-069 | 50268-069-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | May 29, 2008 | TE: | AB | RLD: | No |
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