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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
AvKARE
DUNS: 796560394
Effective Date
January 10, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole(400 mg in 1 1)
Trimethoprim(80 mg in 1 1)

Products2

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
42291-758
Application Number
ANDA076899
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: JE42381TNVClass: ACTIBQuantity: 400 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: AN164J8Y0XClass: ACTIBQuantity: 80 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Sulfamethoxazole and Trimethoprim

Product Details

NDC Product Code
42291-759
Application Number
ANDA076899
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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