Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROSUVASTATIN CALCIUM
Product Details
NDC Product Code
61919-701Application Number
ANDA207616Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 19, 2019CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
RosuvastatinActive
Code: 83MVU38M7QClass: ACTIMQuantity: 20 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT