| 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: | 0603-4111-21 |
| Package Description: | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4111-21) |
| NDC Code | 0603-4111-21 |
| Proprietary Name | Isosorbide Mononitrate |
| Package Description | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4111-21) |
| 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] |