Details for New Drug Application (NDA): 214115
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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 214115
Tradename: | ISOSORBIDE MONONITRATE |
Applicant: | Shandong |
Ingredient: | isosorbide mononitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214115
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 214115
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 214115 | ANDA | Shandong New Time Pharmaceutical Co., Ltd. | 42677-307 | 42677-307-01 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-307-01) |
ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 214115 | ANDA | Shandong New Time Pharmaceutical Co., Ltd. | 42677-307 | 42677-307-02 | 600 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-307-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Apr 29, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Feb 8, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Feb 8, 2024 | TE: | AB | RLD: | No |
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