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FDA Approval

Sulfamethoxazole and Trimethoprim

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Department of State Health Services, Pharmacy Branch
DUNS: 781992540
Effective Date
March 11, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole(800 mg in 1 1)
Trimethoprim(160 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sulfamethoxazole and Trimethoprim

Product Details

NDC Product Code
55695-008
Application Number
ANDA078060
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 11, 2016
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
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