Details for New Drug Application (NDA): 075522
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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 075522
Tradename: | ISOSORBIDE MONONITRATE |
Applicant: | Dexcel Ltd |
Ingredient: | isosorbide mononitrate |
Patents: | 0 |
Pharmacology for NDA: 075522
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 075522
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075522 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-178 | 23155-178-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-01) |
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075522 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-178 | 23155-178-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Apr 17, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Sep 20, 2016 | TE: | AB | RLD: | No |
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