Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
New Horizon Rx Group, LLC
056256127
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals
New Horizon Rx Group, LLC
New Horizon Rx Group, LLC
831227801
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULFAMETHOXAZOLE AND TRIMETHOPRIM double strength
Product Details
NDC Product Code
58517-140Application Number
ANDA076899Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2013SulfamethoxazoleActive
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
TrimethoprimActive
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
POVIDONESInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT