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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
Contract Pharmacy Services-PA
DUNS: 945429777
Effective Date
April 6, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trimethoprim(160 mg in 1 1)
Sulfamethoxazole(800 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
67046-715
Application Number
ANDA078060
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 25, 2009
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
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STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
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Code: F05Q2T2JA0Class: IACT
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Code: OJ245FE5EUClass: IACT
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Code: FZ989GH94EClass: IACT
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Code: 5856J3G2A2Class: IACT
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