NITRO-BID
NITRO-BID (Nitroglycerin Ointment USP, 2%)
Approved
Approval ID
e464e9bb-48e8-4b9f-9fff-e220cfbac0c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2021
Manufacturers
FDA
Savage Laboratories a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0281-0326
Application NumberANDA087355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (4)
nitroglycerinActive
Quantity: 20 mg in 1 g
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT