isosorbide mononitrate
Isosorbide MononitrateExtended-Release TabletsRx only
Approved
Approval ID
cc6293ae-1f81-4670-84b2-c00422c690ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
isosorbide mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-777
Application NumberANDA075155
Product Classification
M
Marketing Category
C73584
G
Generic Name
isosorbide mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2009
FDA Product Classification
INGREDIENTS (1)
ISOSORBIDE MONONITRATEActive
Quantity: 120 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
isosorbide mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-837
Application NumberANDA075155
Product Classification
M
Marketing Category
C73584
G
Generic Name
isosorbide mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2009
FDA Product Classification
INGREDIENTS (1)
ISOSORBIDE MONONITRATEActive
Quantity: 60 mg in 1 1
Code: LX1OH63030
Classification: ACTIB