Details for New Drug Application (NDA): 204331
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NDA 204331 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, and Dr Reddys Labs Sa, and is included in twenty-three 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 204331
| Tradename: | EZETIMIBE |
| Applicant: | Zydus Pharms |
| Ingredient: | ezetimibe |
| Patents: | 0 |
Pharmacology for NDA: 204331
| Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for 204331
Suppliers and Packaging for NDA: 204331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE | ezetimibe | TABLET;ORAL | 204331 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-773 | 68382-773-01 | 100 TABLET in 1 BOTTLE (68382-773-01) |
| EZETIMIBE | ezetimibe | TABLET;ORAL | 204331 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-773 | 68382-773-05 | 500 TABLET in 1 BOTTLE (68382-773-05) |
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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