Details for New Drug Application (NDA): 078560
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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 078560
Tradename: | EZETIMIBE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | ezetimibe |
Patents: | 0 |
Pharmacology for NDA: 078560
Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 078560
Suppliers and Packaging for NDA: 078560
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EZETIMIBE | ezetimibe | TABLET;ORAL | 078560 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-226 | 68462-226-05 | 500 TABLET in 1 BOTTLE (68462-226-05) |
EZETIMIBE | ezetimibe | TABLET;ORAL | 078560 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-226 | 68462-226-10 | 1000 TABLET in 1 BOTTLE (68462-226-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 26, 2015 | TE: | AB | RLD: | No |
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