MedPath
FDA Approval

Bactrim DS

April 29, 2021

HUMAN PRESCRIPTION DRUG LABEL

Trimethoprim(80 mg in 1 1)
Sulfamethoxazole(400 mg in 1 1)

Manufacturing Establishments (2)

ALKALOIDA

Sun Pharmaceutical Industries, Inc

643611692

Frontida BioPharm, Inc.

Sun Pharmaceutical Industries, Inc

080243260

Products (2)

Bactrim

49708-145

NDA017377

NDA (C73594)

ORAL

April 5, 2021

DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: AN164J8Y0XClass: ACTIBQuantity: 80 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: JE42381TNVClass: ACTIBQuantity: 400 mg in 1 1

Bactrim DS

49708-146

NDA017377

NDA (C73594)

ORAL

April 5, 2021

SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
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