MedPath
FDA Approval

ANCOBON

February 2, 2022

HUMAN PRESCRIPTION DRUG LABEL

Flucytosine(500 mg in 1 1)

Manufacturing Establishments (1)

Bausch Health Companies, Inc.

Bausch Health US LLC

253292734

Products (2)

ANCOBON

0187-3555

NDA017001

NDA (C73594)

ORAL

February 2, 2022

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: D83282DT06Class: ACTIBQuantity: 500 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT

ANCOBON

0187-3554

NDA017001

NDA (C73594)

ORAL

February 2, 2022

Code: D83282DT06Class: ACTIBQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
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