Details for New Drug Application (NDA): 076132
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NDA 076132 describes RIMANTADINE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Impax Labs, and Impax Labs Inc, and is included in three NDAs. It is available from one supplier. Additional details are available on the RIMANTADINE HYDROCHLORIDE profile page.
The generic ingredient in RIMANTADINE HYDROCHLORIDE is rimantadine hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rimantadine hydrochloride profile page.
The generic ingredient in RIMANTADINE HYDROCHLORIDE is rimantadine hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rimantadine hydrochloride profile page.
Summary for 076132
| Tradename: | RIMANTADINE HYDROCHLORIDE |
| Applicant: | Impax Labs |
| Ingredient: | rimantadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076132
| Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 076132
Suppliers and Packaging for NDA: 076132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 076132 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1911 | 0115-1911-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01) |
| RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 076132 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1911 | 0115-1911-02 | 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 30, 2002 | TE: | RLD: | No | |||||
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