Details for New Drug Application (NDA): 050475
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NDA 050475 describes GRIS-PEG, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the GRIS-PEG profile page.
The generic ingredient in GRIS-PEG 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 GRIS-PEG 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 050475
| Tradename: | GRIS-PEG |
| Applicant: | Bausch |
| Ingredient: | griseofulvin, ultramicrosize |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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: | Yes | ||||
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