Details for New Drug Application (NDA): 019358
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NDA 019358 describes AZO GANTRISIN, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the AZO GANTRISIN profile page.
The generic ingredient in AZO GANTRISIN is phenazopyridine hydrochloride; sulfisoxazole. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfisoxazole profile page.
The generic ingredient in AZO GANTRISIN is phenazopyridine hydrochloride; sulfisoxazole. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfisoxazole profile page.
Summary for 019358
| Tradename: | AZO GANTRISIN |
| Applicant: | Roche |
| Ingredient: | phenazopyridine hydrochloride; sulfisoxazole |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 31, 1990 | TE: | RLD: | Yes | |||||
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