Drug application
ISOTRETINOIN (ISOTRETINOIN)
Drugs@FDA ANDA 216097 · AMNEAL PHARMS NY
Key facts
| Drug name | ISOTRETINOIN |
|---|---|
| Active ingredients | ISOTRETINOIN |
| Application type | ANDA |
| Application number | 216097 |
| Company | AMNEAL PHARMS NY |
| Dosage forms | CAPSULE, ORAL |
| Strength | 10MG |
| Marketing status | Discontinued |
| TE codes | AB2 |
| Reference listed drug | No |
| Latest submission status date | Oct 7, 2025 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.