# MONTELUKAST SODIUM
> **ANDA078605** · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS · Approved 2012-08-03
## Drug
- **FDA Application Number:** ANDA078605
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MONTELUKAST SODIUM
- **Generic name:** Montelukast Sodium
- **Active ingredients:** MONTELUKAST SODIUM
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** TEVA PHARMS
- **First approval:** 2012-08-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078605)
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