MedPath
FDA Approval

Sulfamethoxazole and Trimethoprim

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

FDA Approval Summary

Company
Redpharm Drug
DUNS: 828374897
Effective Date
November 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole(800 mg in 1 1)
Trimethoprim(160 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Redpharm Drug

Redpharm Drug

828374897

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
67296-1904
Application Number
ANDA076899
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 27, 2023
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SulfamethoxazoleActive
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
TrimethoprimActive
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy