Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Product details
- Generic drug
- Isotretinoin: every company that makes it
- Form
- capsule, oral
- Strength
- 35 mg
- Approval
- ANDA ANDA218194
- On the market since
- Jan 29, 2024
- Package NDCs
59651-635-03- Official label
- DailyMed (National Library of Medicine), updated Sep 29, 2026
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