# EZETIMIBE AND SIMVASTATIN
> **ANDA209222** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2017-12-22
## Drug
- **FDA Application Number:** ANDA209222
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** EZETIMIBE AND SIMVASTATIN
- **Generic name:** EZETIMIBE AND SIMVASTATIN
- **Active ingredients:** EZETIMIBE; SIMVASTATIN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALKEM LABS LTD
- **Manufacturer:** Ascend Laboratories, LLC
- **First approval:** 2017-12-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209222)
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