Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | India | Makes it and tests 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
- 10 mg
- Approval
- ANDA ANDA202099
- On the market since
- Dec 30, 2025
- Package NDCs
68001-652-1668001-652-17- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2026
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