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FDA Approval

Meperidine Hydrochloride

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

May 6, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Meperidine(50 mg in 1 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Meperidine Hydrochloride

NDC Product Code

54868-3559

Application Number

ANDA080455

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR

Effective Date

May 6, 2010

Ingredients

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

MeperidineActive

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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