Details for New Drug Application (NDA): 090598
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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 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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