| Product NDC: | 13668-105 | 
| 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: | 13668-105 | 
| Labeler Name: | Torrent Pharmaceuticals Limited | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA200495 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20110603 | 
| Package NDC: | 13668-105-10 | 
| Package Description: | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-10) | 
| NDC Code | 13668-105-10 | 
| Proprietary Name | ISOSORBIDE MONONITRATE | 
| Package Description | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-10) | 
| Product NDC | 13668-105 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | ISOSORBIDE MONONITRATE | 
| Dosage Form Name | TABLET, EXTENDED RELEASE | 
| Route Name | ORAL | 
| Start Marketing Date | 20110603 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Torrent Pharmaceuticals Limited | 
| Substance Name | ISOSORBIDE MONONITRATE | 
| Strength Number | 60 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes |