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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 018615


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NDA 018615 describes SULFATRIM PEDIATRIC, which is a drug marketed by Pharm Assoc and is included in one NDA. It is available from three suppliers. Additional details are available on the SULFATRIM PEDIATRIC profile page.

The generic ingredient in SULFATRIM PEDIATRIC is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
Summary for 018615
Tradename:SULFATRIM PEDIATRIC
Applicant:Pharm Assoc
Ingredient:sulfamethoxazole; trimethoprim
Patents:0
Suppliers and Packaging for NDA: 018615
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFATRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA Pharmaceutical Associates, Inc. 0121-0853 0121-0853-00 10 TRAY in 1 CASE (0121-0853-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (0121-0853-20)
SULFATRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA Pharmaceutical Associates, Inc. 0121-0853 0121-0853-40 4 TRAY in 1 CASE (0121-0853-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (0121-0853-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML
Approval Date:Jan 7, 1983TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML
Approval Date:Jan 7, 1983TE:RLD:No

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