Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Golden State Medical Supply, Inc.
Golden State Medical Supply, Inc.
603184490
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rosuvastatin
Product Details
NDC Product Code
51407-851Application Number
ANDA206381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 15, 2024CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
RosuvastatinActive
Code: 413KH5ZJ73Class: ACTIBQuantity: 40 mg in 1 1
Rosuvastatin
Product Details
NDC Product Code
51407-849Application Number
ANDA206381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 15, 2024CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
RosuvastatinActive
Code: 413KH5ZJ73Class: ACTIBQuantity: 10 mg in 1 1
Rosuvastatin
Product Details
NDC Product Code
51407-848Application Number
ANDA206381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 15, 2024CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
RosuvastatinActive
Code: 413KH5ZJ73Class: ACTIBQuantity: 5 mg in 1 1
Rosuvastatin
Product Details
NDC Product Code
51407-850Application Number
ANDA206381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 15, 2024CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
RosuvastatinActive
Code: 413KH5ZJ73Class: ACTIBQuantity: 20 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT