Product NDC: | 52125-422 |
Proprietary Name: | Isosorbide |
Non Proprietary Name: | Isosorbide mononitrate |
Active Ingredient(s): | 30 mg/1 & nbsp; Isosorbide mononitrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52125-422 |
Labeler Name: | REMEDYREPACK INC. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076813 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130515 |
Package NDC: | 52125-422-02 |
Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (52125-422-02) |
NDC Code | 52125-422-02 |
Proprietary Name | Isosorbide |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (52125-422-02) |
Product NDC | 52125-422 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Isosorbide mononitrate |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20130515 |
Marketing Category Name | ANDA |
Labeler Name | REMEDYREPACK INC. |
Substance Name | ISOSORBIDE MONONITRATE |
Strength Number | 30 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |