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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 017598


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NDA 017598 describes SEPTRA GRAPE, which is a drug marketed by Monarch Pharms and is included in one NDA. Additional details are available on the SEPTRA GRAPE profile page.

The generic ingredient in SEPTRA GRAPE is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
Summary for 017598
Tradename:SEPTRA GRAPE
Applicant:Monarch Pharms
Ingredient:sulfamethoxazole; trimethoprim
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 12, 1986TE:RLD:No

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