Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRAVASTATIN SODIUM
Product Details
NDC Product Code
82009-006Application Number
ANDA076341Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 5, 2023PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 20 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PRAVASTATIN SODIUM
Product Details
NDC Product Code
82009-007Application Number
ANDA076341Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 5, 2023PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 40 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PRAVASTATIN SODIUM
Product Details
NDC Product Code
82009-008Application Number
ANDA076341Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 5, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 80 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT