Details for New Drug Application (NDA): 075522
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NDA 075522 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma Intl, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, Genus, and Hikma Pharms, and is included in twenty NDAs. It is available from twenty-one suppliers. Additional details are available on the ISOSORBIDE MONONITRATE profile page.
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.
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 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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