Details for New Drug Application (NDA): 065394
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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 065394
Tradename: | GRISEOFULVIN |
Applicant: | Actavis Mid Atlantic |
Ingredient: | griseofulvin, microsize |
Patents: | 0 |
Pharmacology for NDA: 065394
Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 065394
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GRISEOFULVIN | griseofulvin, microsize | SUSPENSION;ORAL | 065394 | ANDA | Actavis Pharma, Inc. | 0472-0013 | 0472-0013-04 | 120 mL in 1 BOTTLE (0472-0013-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
Approval Date: | Jul 6, 2007 | TE: | AB | RLD: | No |
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