MedPath
FDA Approval

Captopril

April 12, 2011

HUMAN PRESCRIPTION DRUG LABEL

Captopril(50 mg in 1 1)

Manufacturing Establishments (1)

Legacy Pharmaceutical Packaging

Legacy Pharmaceutical Packaging

143213275

Products (4)

Captopril

68645-162

ANDA074532

ANDA (C73584)

ORAL

April 11, 2011

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1Class: IACT

Captopril

68645-161

ANDA074532

ANDA (C73584)

ORAL

April 11, 2011

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1Class: IACT

Captopril

68645-160

ANDA074532

ANDA (C73584)

ORAL

April 11, 2011

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 12.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1Class: IACT

Captopril

68645-163

ANDA074532

ANDA (C73584)

ORAL

April 11, 2011

CaptoprilActive
Code: 9G64RSX1XDClass: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1Class: IACT
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