Details for New Drug Application (NDA): 078720
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NDA 078720 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Zydus, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Onesource Specialty, Rising, Rubicon Research, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Adaptis, Aurobindo Pharma Usa, Chartwell Rx, G And W Labs Inc, Ph Health, Pharm Assoc, Pharmobedient, Pom Pharma, Teva Pharms, Jubilant Generics, and Zhejiang Jutai Pharm, and is included in thirty-six NDAs. It is available from thirty-four 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. Thirty-six suppliers are listed for this compound. 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. Thirty-six 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 |
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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