Details for New Drug Application (NDA): 200495
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NDA 200495 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-three 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-five 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-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 200495
| Tradename: | ISOSORBIDE MONONITRATE |
| Applicant: | Torrent Pharms |
| Ingredient: | isosorbide mononitrate |
| Patents: | 0 |
Pharmacology for NDA: 200495
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 200495
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 200495 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7768 | 0615-7768-05 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05) |
| ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 200495 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7768 | 0615-7768-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Jun 3, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Jun 3, 2011 | TE: | AB | RLD: | No | ||||
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