Details for New Drug Application (NDA): 075155
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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-three suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 075155
Tradename: | ISOSORBIDE MONONITRATE |
Applicant: | Chartwell Molecular |
Ingredient: | isosorbide mononitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075155
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 075155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075155 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-313 | 43063-313-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-313-30) |
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075155 | ANDA | Lannett Company, Inc. | 62175-119 | 62175-119-37 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-119-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Oct 30, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 13, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Aug 4, 2000 | TE: | AB | RLD: | No |
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