Details for New Drug Application (NDA): 210822
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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-four suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 210822
Tradename: | ISOSORBIDE MONONITRATE |
Applicant: | Dexcel Ltd |
Ingredient: | isosorbide mononitrate |
Patents: | 0 |
Pharmacology for NDA: 210822
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 210822
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 210822 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-628 | 23155-628-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-628-01) |
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 210822 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-960 | 42799-960-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-960-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Aug 29, 2018 | TE: | AB | RLD: | No |
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