Nitroglycerin Transdermal Delivery System
Approved
Approval ID
fcd4cf8a-e3e6-7da9-6355-c60b7400291a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2009
Manufacturers
FDA
Graceway Pharmaceuticals, LLC
DUNS: 613448161
Products 4
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 Code29336-321
Application NumberANDA089771
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateNovember 23, 2009
FDA Product Classification
INGREDIENTS (1)
nitroglycerinActive
Quantity: 2.5 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29336-324
Application NumberANDA089774
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateNovember 23, 2009
FDA Product Classification
INGREDIENTS (1)
nitroglycerinActive
Quantity: 15 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29336-323
Application NumberANDA089773
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateNovember 23, 2009
FDA Product Classification
INGREDIENTS (1)
nitroglycerinActive
Quantity: 10 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29336-322
Application NumberANDA089772
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateNovember 23, 2009
FDA Product Classification
INGREDIENTS (1)
nitroglycerinActive
Quantity: 5 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM