Details for New Drug Application (NDA): 209234
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NDA 209234 describes EZETIMIBE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa, and is included in twenty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the EZETIMIBE profile page.
The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Twelve 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 |
| Formulation / Manufacturing: | see details |
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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