Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it, makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, makes the active ingredient, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- granule, oral
- Strength
- 4 mg per 500 mg
- Approval
- ANDA ANDA210431
- On the market since
- Mar 30, 2017
- Package NDCs
13668-531-1113668-531-94- Official label
- DailyMed (National Library of Medicine), updated Jul 28, 2026
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