Details for New Drug Application (NDA): 062438
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NDA 062438 describes GRISACTIN ULTRA, which is a drug marketed by Wyeth Ayerst and is included in two NDAs. Additional details are available on the GRISACTIN ULTRA profile page.
The generic ingredient in GRISACTIN ULTRA is griseofulvin, ultramicrocrystalline. There is one drug master file entry for this compound. Additional details are available on the griseofulvin, ultramicrocrystalline profile page.
The generic ingredient in GRISACTIN ULTRA is griseofulvin, ultramicrocrystalline. There is one drug master file entry for this compound. Additional details are available on the griseofulvin, ultramicrocrystalline profile page.
Summary for 062438
| Tradename: | GRISACTIN ULTRA |
| Applicant: | Wyeth Ayerst |
| Ingredient: | griseofulvin, ultramicrocrystalline |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 165MG | ||||
| Approval Date: | Nov 17, 1983 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 330MG | ||||
| Approval Date: | Nov 17, 1983 | TE: | RLD: | No | |||||
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