Details for New Drug Application (NDA): 204371
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NDA 204371 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 204371
| Tradename: | GRISEOFULVIN, ULTRAMICROSIZE |
| Applicant: | Mountain |
| Ingredient: | griseofulvin, ultramicrosize |
| Patents: | 0 |
Pharmacology for NDA: 204371
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 204371
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRISEOFULVIN, ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 204371 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1724 | 0115-1724-01 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-01) |
| GRISEOFULVIN, ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 204371 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1724 | 0115-1724-02 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Jan 9, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jan 9, 2014 | TE: | AB | RLD: | No | ||||
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