Details for New Drug Application (NDA): 209222
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NDA 209222 describes EZETIMIBE AND SIMVASTATIN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Watson Labs Inc, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the EZETIMIBE AND SIMVASTATIN profile page.
The generic ingredient in EZETIMIBE AND SIMVASTATIN 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 AND SIMVASTATIN 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 209222
| Tradename: | EZETIMIBE AND SIMVASTATIN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | ezetimibe; simvastatin |
| Patents: | 0 |
Pharmacology for NDA: 209222
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Physiological Effect | Decreased Cholesterol Absorption |
Suppliers and Packaging for NDA: 209222
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 209222 | ANDA | A-S Medication Solutions | 50090-4772 | 50090-4772-0 | 90 TABLET in 1 BOTTLE (50090-4772-0) |
| EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 209222 | ANDA | Ascend Laboratories, LLC | 67877-507 | 67877-507-01 | 1000 TABLET in 1 BOTTLE (67877-507-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;10MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;40MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
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