Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TELMISARTAN
Product Details
NDC Product Code
62135-535Application Number
ANDA078710Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 20 mg in 1 1
TELMISARTAN
Product Details
NDC Product Code
62135-537Application Number
ANDA078710Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 80 mg in 1 1
TELMISARTAN
Product Details
NDC Product Code
62135-536Application Number
ANDA078710Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 40 mg in 1 1
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT