Details for New Drug Application (NDA): 208699
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NDA 208699 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 twelve 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 208699
| Tradename: | EZETIMIBE AND SIMVASTATIN |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ezetimibe; simvastatin |
| Patents: | 0 |
Pharmacology for NDA: 208699
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Physiological Effect | Decreased Cholesterol Absorption |
Suppliers and Packaging for NDA: 208699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208699 | ANDA | NORTHSTAR RX LLC | 16714-778 | 16714-778-01 | 30 TABLET in 1 BOTTLE (16714-778-01) |
| EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208699 | ANDA | NORTHSTAR RX LLC | 16714-778 | 16714-778-02 | 90 TABLET in 1 BOTTLE (16714-778-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;10MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;40MG | ||||
| Approval Date: | Jun 27, 2019 | TE: | AB | RLD: | No | ||||
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