MedPath
FDA Approval

Captopril

April 20, 2023

HUMAN PRESCRIPTION DRUG LABEL

Captopril(25 mg in 1 1)

Products (4)

Captopril

43547-364

ANDA074477

ANDA (C73584)

ORAL

April 20, 2023

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Captopril

43547-365

ANDA074477

ANDA (C73584)

ORAL

April 20, 2023

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 50 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Captopril

43547-363

ANDA074477

ANDA (C73584)

ORAL

April 20, 2023

STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 12.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Captopril

43547-366

ANDA074477

ANDA (C73584)

ORAL

April 20, 2023

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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