Details for New Drug Application (NDA): 202482
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NDA 202482 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette, Sandoz, Sigmapharm Labs Llc, and Mountain, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the GRISEOFULVIN profile page.
The generic ingredient in GRISEOFULVIN is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
The generic ingredient in GRISEOFULVIN is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 202482
| Tradename: | GRISEOFULVIN |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | griseofulvin, microsize |
| Patents: | 0 |
Pharmacology for NDA: 202482
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 202482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRISEOFULVIN | griseofulvin, microsize | TABLET;ORAL | 202482 | ANDA | Sigmapharm Laboratories, LLC | 42794-012 | 42794-012-08 | 30 TABLET in 1 BOTTLE (42794-012-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Oct 22, 2012 | TE: | AB | RLD: | No | ||||
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