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FDA Approval

GONITRO

CompanyEspero Pharmaceuticals, Inc. (DUNS: 079905661)

Effective Date

June 20, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nitroglycerin(400 ug in 1 1)

Products (1)

GONITRO

NDC Product Code

70007-400

Application Number

NDA208424

Marketing Category

NDA (C73594)

Route of Administration

SUBLINGUAL

Effective Date

June 30, 2016

Ingredients

NitroglycerinActive

Code: G59M7S0WS3Class: ACTIBQuantity: 400 ug in 1 1

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7UClass: IACT

PEPPERMINT OILInactive

Code: AV092KU4JHClass: IACT

ISOMALTInactive

Code: S870P55O2WClass: IACT

PEG-5 oleateInactive

Code: 0240V77G50Class: IACT

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