Details for New Drug Application (NDA): 215693
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The generic ingredient in EZETIMIBE 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 215693
Tradename: | EZETIMIBE |
Applicant: | Orient Pharma |
Ingredient: | ezetimibe |
Patents: | 0 |
Pharmacology for NDA: 215693
Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 215693
Suppliers and Packaging for NDA: 215693
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EZETIMIBE | ezetimibe | TABLET;ORAL | 215693 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-787 | 10135-787-05 | 500 TABLET in 1 BOTTLE (10135-787-05) |
EZETIMIBE | ezetimibe | TABLET;ORAL | 215693 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-787 | 10135-787-30 | 30 TABLET in 1 BOTTLE (10135-787-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 13, 2022 | TE: | AB | RLD: | No |
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