Details for New Drug Application (NDA): 208803
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NDA 208803 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, 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-four 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 208803
| Tradename: | EZETIMIBE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | ezetimibe |
| Patents: | 0 |
Pharmacology for NDA: 208803
| Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 208803
Suppliers and Packaging for NDA: 208803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | ezetimibe | TABLET;ORAL | 208803 | ANDA | AvPAK | 50268-298 | 50268-298-12 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11) |
| EZETIMIBE | ezetimibe | TABLET;ORAL | 208803 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1154 | 69238-1154-1 | 1000 TABLET in 1 BOTTLE (69238-1154-1) |
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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