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FDA Approval

Proctocort

CompanySalix Pharmaceuticals, Inc (DUNS: 793108036)

Effective Date

April 1, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone acetate(30 mg in 1 1)

Manufacturing Establishments (1)

Paddock Laboratories, LLC

Labeler

Salix Pharmaceuticals, Inc

DUNS Number

967694121

Products (1)

Proctocort

NDC Product Code

65649-511

Route of Administration

RECTAL

Effective Date

April 1, 2016

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Hydrocortisone acetateActive

Code: 3X7931PO74Class: ACTIBQuantity: 30 mg in 1 1

HYDROGENATED PALM OILInactive

Code: 257THB963HClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

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