Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it, tests it and packages it | No problems foundAug 30, 2019 · 6 inspections |
| Kemwell Biopharma Private Limited | Location not on file | Makes it, tests it and packages it | Not inspected on record |
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable
- Strength
- 5 mg
- Approval
- ANDA ANDA203037
- On the market since
- Dec 1, 2014
- Package NDCs
0143-9650-090143-9650-100143-9650-30- Official label
- DailyMed (National Library of Medicine), updated Jun 24, 2015
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