Details for New Drug Application (NDA): 209838
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NDA 209838 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, Macleods Pharms Ltd, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, and Torrent, and is included in twenty-five NDAs. It is available from twenty-seven 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 209838
| Tradename: | EZETIMIBE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ezetimibe |
| Patents: | 0 |
Pharmacology for NDA: 209838
| Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 209838
Suppliers and Packaging for NDA: 209838
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | ezetimibe | TABLET;ORAL | 209838 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8300 | 0615-8300-05 | 15 TABLET in 1 BLISTER PACK (0615-8300-05) |
| EZETIMIBE | ezetimibe | TABLET;ORAL | 209838 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8300 | 0615-8300-39 | 30 TABLET in 1 BLISTER PACK (0615-8300-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 25, 2017 | TE: | AB | RLD: | No | ||||
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