Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Aurobindo Pharma Limited
650082092
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
APL HEALTHCARE LIMITED
Cronus Pharma LLC
Aurobindo Pharma Limited
650844777
Aurobindo Pharma Limited
Cronus Pharma LLC
Aurobindo Pharma Limited
650381903
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
69043-011Application Number
ANDA090624Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 3, 2021SulfamethoxazoleActive
Code: JE42381TNVClass: ACTIBQuantity: 800 mg in 1 1
TrimethoprimActive
Code: AN164J8Y0XClass: ACTIBQuantity: 160 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
Sulfamethoxazole and Trimethoprim
Product Details
NDC Product Code
69043-010Application Number
ANDA090624Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 3, 2021TrimethoprimActive
Code: AN164J8Y0XClass: ACTIBQuantity: 80 mg in 1 1
SulfamethoxazoleActive
Code: JE42381TNVClass: ACTIBQuantity: 400 mg in 1 1
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT