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FDA Approval

Nitroglycerin

CompanyAmerican Regent, Inc. (DUNS: 002033710)

Effective Date

July 22, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nitroglycerin(5 mg in 1 mL)

Manufacturing Establishments (1)

American Regent, Inc.

Labeler

American Regent, Inc.

DUNS Number

002033710

Products (1)

Nitroglycerin

NDC Product Code

0517-4810

Application Number

ANDA072034

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

July 22, 2021

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

NitroglycerinActive

Code: G59M7S0WS3Class: ACTIBQuantity: 5 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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