Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 12, 2023 · 1 inspection |
Product details
- Generic drug
- Isotretinoin: every company that makes it
- Form
- capsule, gelatin coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA202099
- On the market since
- Dec 24, 2025
- Package NDCs
68001-655-1668001-655-17- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2026
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