Details for New Drug Application (NDA): 090598
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NDA 090598 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, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, and Hikma Pharms, and is included in twenty NDAs. It is available from twenty-two 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 090598
| Tradename: | ISOSORBIDE MONONITRATE |
| Applicant: | Strides Pharma |
| Ingredient: | isosorbide mononitrate |
| Patents: | 0 |
Pharmacology for NDA: 090598
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 090598
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 090598 | ANDA | Proficient Rx LP | 63187-700 | 63187-700-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-30) |
| ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 090598 | ANDA | Proficient Rx LP | 63187-700 | 63187-700-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 11, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Aug 11, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Aug 11, 2010 | TE: | RLD: | No | |||||
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