ANDA 202577, held by Mylan Pharms Inc. Fentanyl.
As of Nov 13, 2026, ANDA 202577 (Fentanyl), held by Mylan Pharms Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2015 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fentanyl100MCG · tablet;buccal | Fentanyl | None (tentative approval) |
| Fentanyl200MCG · tablet;buccal | Fentanyl | None (tentative approval) |
| Fentanyl300MCG · tablet;buccal | Fentanyl | None (tentative approval) |
| Fentanyl400MCG · tablet;buccal | Fentanyl | None (tentative approval) |
| Fentanyl600MCG · tablet;buccal | Fentanyl | None (tentative approval) |
| Fentanyl800MCG · tablet;buccal | Fentanyl | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters