Product NDC: | 0603-4111 |
Proprietary Name: | Isosorbide Mononitrate |
Non Proprietary Name: | Isosorbide Mononitrate |
Active Ingredient(s): | 60 mg/1 & nbsp; Isosorbide Mononitrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0603-4111 |
Labeler Name: | Qualitest Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090598 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100811 |
Package NDC: | 0603-4111-10 |
Package Description: | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4111-10) |
NDC Code | 0603-4111-10 |
Proprietary Name | Isosorbide Mononitrate |
Package Description | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4111-10) |
Product NDC | 0603-4111 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Isosorbide Mononitrate |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20100811 |
Marketing Category Name | ANDA |
Labeler Name | Qualitest Pharmaceuticals |
Substance Name | ISOSORBIDE MONONITRATE |
Strength Number | 60 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |