Details for New Drug Application (NDA): 091592
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NDA 091592 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 091592
| Tradename: | GRISEOFULVIN |
| Applicant: | Sandoz |
| Ingredient: | griseofulvin, microsize |
| Patents: | 0 |
Pharmacology for NDA: 091592
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 091592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRISEOFULVIN | griseofulvin, microsize | TABLET;ORAL | 091592 | ANDA | Sandoz Inc | 0781-5514 | 0781-5514-01 | 100 TABLET in 1 BOTTLE (0781-5514-01) |
| GRISEOFULVIN | griseofulvin, microsize | TABLET;ORAL | 091592 | ANDA | Sandoz Inc | 0781-5514 | 0781-5514-05 | 500 TABLET in 1 BOTTLE (0781-5514-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 7, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 7, 2013 | TE: | AB | RLD: | No | ||||
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