Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
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
50090-5490Application Number
ANDA202397Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 22, 2018MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 40 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT