Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
71335-9640Application Number
ANDA207408Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 23, 2020ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
RosuvastatinActive
Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT