Details for New Drug Application (NDA): 202805
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NDA 202805 describes GRISEOFULVIN, ULTRAMICROSIZE, which is a drug marketed by Mountain and Sandoz and is included in two NDAs. It is available from two suppliers. Additional details are available on the GRISEOFULVIN, ULTRAMICROSIZE profile page.
The generic ingredient in GRISEOFULVIN, ULTRAMICROSIZE 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, ULTRAMICROSIZE 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 202805
| Tradename: | GRISEOFULVIN, ULTRAMICROSIZE |
| Applicant: | Sandoz |
| Ingredient: | griseofulvin, ultramicrosize |
| Patents: | 0 |
Pharmacology for NDA: 202805
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 202805
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRISEOFULVIN, ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 202805 | ANDA | Sandoz Inc | 0781-5827 | 0781-5827-01 | 100 TABLET, COATED in 1 BOTTLE (0781-5827-01) |
| GRISEOFULVIN, ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 202805 | ANDA | Sandoz Inc | 0781-5827 | 0781-5827-05 | 500 TABLET, COATED in 1 BOTTLE (0781-5827-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Dec 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Dec 26, 2018 | TE: | AB | RLD: | No | ||||
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