Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals
Northwind Pharmaceuticals
Northwind Pharmaceuticals
036986393
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
51655-996Application Number
ANDA208898Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2023CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
RosuvastatinActive
Code: 83MVU38M7QClass: ACTIMQuantity: 20 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT