# MONTELUKAST SODIUM
> **ANDA203366** · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2014-09-11
## Drug
- **FDA Application Number:** ANDA203366
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MONTELUKAST SODIUM
- **Generic name:** MONTELUKAST
- **Active ingredients:** MONTELUKAST SODIUM
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** MACLEODS PHARMS LTD
- **Manufacturer:** BluePoint Laboratories
- **First approval:** 2014-09-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203366)
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*MORVS · CC0 1.0*