Details for New Drug Application (NDA): 075037
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The generic ingredient in ISOSORBIDE MONONITRATE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 075037
Tradename: | ISOSORBIDE MONONITRATE |
Applicant: | Actavis Elizabeth |
Ingredient: | isosorbide mononitrate |
Patents: | 0 |
Pharmacology for NDA: 075037
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 075037
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET;ORAL | 075037 | ANDA | Actavis Pharma, Inc. | 0228-2620 | 0228-2620-11 | 100 TABLET in 1 BOTTLE (0228-2620-11) |
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET;ORAL | 075037 | ANDA | Actavis Pharma, Inc. | 0228-2631 | 0228-2631-11 | 100 TABLET in 1 BOTTLE (0228-2631-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 30, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 30, 1998 | TE: | AB | RLD: | No |
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