Details for New Drug Application (NDA): 060569
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NDA 060569 describes FULVICIN-U/F, which is a drug marketed by Chartwell Rx and is included in one NDA. It is available from two suppliers. Additional details are available on the FULVICIN-U/F profile page.
The generic ingredient in FULVICIN-U/F is griseofulvin, microsize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, microsize profile page.
The generic ingredient in FULVICIN-U/F is griseofulvin, microsize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, microsize profile page.
Summary for 060569
| Tradename: | FULVICIN-U/F |
| Applicant: | Chartwell Rx |
| Ingredient: | griseofulvin, microsize |
| Patents: | 0 |
Pharmacology for NDA: 060569
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
Suppliers and Packaging for NDA: 060569
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FULVICIN-U/F | griseofulvin, microsize | TABLET;ORAL | 060569 | ANDA | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-865 | 23155-865-01 | 100 TABLET in 1 BOTTLE, PLASTIC (23155-865-01) |
| FULVICIN-U/F | griseofulvin, microsize | TABLET;ORAL | 060569 | ANDA | Chartwell RX, LLC. | 62135-496 | 62135-496-01 | 100 TABLET in 1 BOTTLE (62135-496-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
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