Basic Information
ROSUVASTATIN CALCIUM
61919-701
Regulatory Information
61919-701
ANDA207616
C73584
August 19, 2019
USA
ROSUVASTATIN CALCIUM
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
079254320
Active Ingredients
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
CROSPOVIDONE (15 MPA.S AT 5%)
Code: 68401960MK
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
SODIUM BICARBONATE
Code: 8MDF5V39QO
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
ANHYDROUS LACTOSE
Code: 3SY5LH9PMK
FOOD YELLOW 3 FREE ACID
Code: G2B7JWK1GG
ROSUVASTATIN
Code: 413KH5ZJ73