Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products2
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
71205-390Application Number
ANDA207408Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2022RosuvastatinActive
Code: 83MVU38M7QClass: ACTIMQuantity: 20 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Rosuvastatin Calcium
Product Details
NDC Product Code
71205-475Application Number
ANDA207408Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2022RosuvastatinActive
Code: 83MVU38M7QClass: ACTIMQuantity: 40 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT