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FDA Approval

PRED MILD

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

January 2, 2013

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Prednisolone acetate(1.2 mg in 1 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

PRED MILD

NDC Product Code

54868-6355

Application Number

NDA017100

Marketing Category

NDA (C73594)

Route of Administration

OPHTHALMIC

Effective Date

January 2, 2013

Ingredients

Prednisolone acetateActive

Code: 8B2807733DClass: ACTIBQuantity: 1.2 mg in 1 mL

boric acidInactive

Code: R57ZHV85D4Class: IACT

benzalkonium chlorideInactive

Code: F5UM2KM3W7Class: IACT

hypromellosesInactive

Code: 3NXW29V3WOClass: IACT

edetate disodiumInactive

Code: 7FLD91C86KClass: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

sodium bisulfiteInactive

Code: TZX5469Z6IClass: IACT

sodium citrateInactive

Code: 1Q73Q2JULRClass: IACT

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