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Details for New Drug Application (NDA): 062759

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NDA 062759 describes ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, which is a drug marketed by Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL profile page.

The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are ninety-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.

Summary for NDA: 062759

Pharmacology for NDA: 062759

Suppliers and Packaging for NDA: 062759

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
erythromycin ethylsuccinate; sulfisoxazole acetyl
GRANULE;ORAL 062759 ANDA Rebel Distributors Corp 21695-690 21695-690-00 100 mL in 1 BOTTLE (21695-690-00)
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
erythromycin ethylsuccinate; sulfisoxazole acetyl
GRANULE;ORAL 062759 ANDA Physicians Total Care, Inc. 54868-0971 54868-0971-1 100 mL in 1 BOTTLE (54868-0971-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 200MG BASE/5ML;EQ 600MG BASE/5ML
Approval Date:May 20, 1988TE:RLD:Yes


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