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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
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Effective Date
February 16, 2021
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.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-4431
Application Number
ANDA090624
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 16, 2021
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SulfamethoxazoleActive
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
TrimethoprimActive
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
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