Details for New Drug Application (NDA): 021687
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The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 021687
Tradename: | VYTORIN |
Applicant: | Organon |
Ingredient: | ezetimibe; simvastatin |
Patents: | 0 |
Pharmacology for NDA: 021687
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Physiological Effect | Decreased Cholesterol Absorption |
Suppliers and Packaging for NDA: 021687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687 | NDA | Organon LLC | 78206-174 | 78206-174-01 | 30 TABLET in 1 BOTTLE (78206-174-01) |
VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687 | NDA | Organon LLC | 78206-174 | 78206-174-02 | 90 TABLET in 1 BOTTLE (78206-174-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;10MG | ||||
Approval Date: | Jul 23, 2004 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
Approval Date: | Jul 23, 2004 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;40MG | ||||
Approval Date: | Jul 23, 2004 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021687
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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