NITROGLYCERIN LINGUAL
These highlights do not include all the information needed to use NITROGLYCERIN LINGUAL SPRAY safely and effectively. See full prescribing information for NITROGLYCERIN LINGUAL SPRAY . NITROGLYCERIN LINGUAL SPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997
Approved
Approval ID
fadd07b7-189b-4678-ad0f-bf1e4d3d1300
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Allegis Pharmaceuticals, LLC
DUNS: 792272861
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 Code28595-120
Application NumberNDA018705
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
NITROGLYCERINActive
Quantity: 400 ug in 1 1
Code: G59M7S0WS3
Classification: ACTIB