Manufacturing Establishments (1)
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
Products (3)
Codeine sulfate
0054-0244
NDA022402
NDA (C73594)
ORAL
March 15, 2021
CodeineActive
Code: 11QV9BS0CBClass: ACTIBQuantity: 30 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Codeine sulfate
0054-0245
NDA022402
NDA (C73594)
ORAL
March 15, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CodeineActive
Code: 11QV9BS0CBClass: ACTIBQuantity: 60 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Codeine sulfate
0054-0243
NDA022402
NDA (C73594)
ORAL
March 15, 2021
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CodeineActive
Code: 11QV9BS0CBClass: ACTIBQuantity: 15 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT