GONITRO
These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
Approved
Approval ID
1418d832-4a6a-45ab-8414-25e23f393abb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 2018
Manufacturers
FDA
Espero Pharmaceuticals, Inc.
DUNS: 079905661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70007-400
Application NumberNDA208424
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJune 30, 2016
FDA Product Classification
INGREDIENTS (6)
NITROGLYCERINActive
Quantity: 400 ug in 1 1
Code: G59M7S0WS3
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
PEG-5 oleateInactive
Code: 0240V77G50
Classification: IACT