Details for New Drug Application (NDA): 062279
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NDA 062279 describes GRIFULVIN V, which is a drug marketed by Johnson And Johnson, Valeant Luxembourg, and J And J, and is included in four NDAs. Additional details are available on the GRIFULVIN V profile page.
The generic ingredient in GRIFULVIN V 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 GRIFULVIN V 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 062279
| Tradename: | GRIFULVIN V |
| Applicant: | Valeant Luxembourg |
| Ingredient: | griseofulvin, microsize |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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