Details for New Drug Application (NDA): 050529
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NDA 050529 describes PEDIAZOLE, which is a drug marketed by Ross Labs and is included in one NDA. Additional details are available on the PEDIAZOLE profile page.
The generic ingredient in PEDIAZOLE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
The generic ingredient in PEDIAZOLE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
Summary for 050529
| Tradename: | PEDIAZOLE |
| Applicant: | Ross Labs |
| Ingredient: | erythromycin ethylsuccinate; sulfisoxazole acetyl |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML;EQ 600MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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