Details for New Drug Application (NDA): 209234
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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 209234
Tradename: | EZETIMIBE |
Applicant: | Alkem Labs Ltd |
Ingredient: | ezetimibe |
Patents: | 0 |
Pharmacology for NDA: 209234
Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 209234
Suppliers and Packaging for NDA: 209234
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EZETIMIBE | ezetimibe | TABLET;ORAL | 209234 | ANDA | Major Pharmaceuticals | 0904-7103 | 0904-7103-04 | 30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK |
EZETIMIBE | ezetimibe | TABLET;ORAL | 209234 | ANDA | Major Pharmaceuticals | 0904-7103 | 0904-7103-10 | 20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 21, 2017 | TE: | AB | RLD: | No |
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