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FDA Approval

BLEPHAMIDE

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

March 4, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sulfacetamide(100 mg in 1 g)

Prednisolone acetate(2 mg in 1 g)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

BLEPHAMIDE

NDC Product Code

54868-1157

Application Number

ANDA087748

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

March 4, 2012

Ingredients

SulfacetamideActive

Code: 4NRT660KJQClass: ACTIBQuantity: 100 mg in 1 g

Prednisolone acetateActive

Code: 8B2807733DClass: ACTIBQuantity: 2 mg in 1 g

phenylmercuric acetateInactive

Code: OSX88361UXClass: IACT

petrolatumInactive

Code: 4T6H12BN9UClass: IACT

mineral oilInactive

Code: T5L8T28FGPClass: IACT

lanolin alcoholsInactive

Code: 884C3FA9HEClass: IACT

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