Details for New Drug Application (NDA): 200495
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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 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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