Registrants (1)
Manufacturing Establishments (1)
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe
Epic Pharma, LLC
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe
080230346
Products (1)
GEMFIBROZIL
42806-260
ANDA078012
ANDA (C73584)
ORAL
December 27, 2023
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GemfibrozilActive
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT