Details for New Drug Application (NDA): 203931
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NDA 203931 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, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms, 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-three suppliers. Additional details are available on the EZETIMIBE profile page.
The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are two drug master file entries for this compound. Eight 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 two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Pharmacology for NDA: 203931
| Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 203931
Suppliers and Packaging for NDA: 203931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | ezetimibe | TABLET;ORAL | 203931 | ANDA | Bryant Ranch Prepack | 63629-7413 | 63629-7413-1 | 30 TABLET in 1 BOTTLE (63629-7413-1) |
| EZETIMIBE | ezetimibe | TABLET;ORAL | 203931 | ANDA | Bryant Ranch Prepack | 63629-7413 | 63629-7413-2 | 90 TABLET in 1 BOTTLE (63629-7413-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 12, 2017 | TE: | AB | RLD: | No | ||||
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