Details for New Drug Application (NDA): 208831
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The generic ingredient in EZETIMIBE AND SIMVASTATIN 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 208831
Tradename: | EZETIMIBE AND SIMVASTATIN |
Applicant: | Amneal Pharms Co |
Ingredient: | ezetimibe; simvastatin |
Patents: | 0 |
Pharmacology for NDA: 208831
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Physiological Effect | Decreased Cholesterol Absorption |
Suppliers and Packaging for NDA: 208831
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208831 | ANDA | AvKARE | 42291-078 | 42291-078-10 | 1000 TABLET in 1 BOTTLE (42291-078-10) |
EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208831 | ANDA | AvKARE | 42291-079 | 42291-079-10 | 1000 TABLET in 1 BOTTLE (42291-079-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;10MG | ||||
Approval Date: | Nov 21, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
Approval Date: | Nov 21, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;40MG | ||||
Approval Date: | Nov 21, 2017 | TE: | AB | RLD: | No |
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