ANDA 207338, held by Actavis Labs Fl Inc. Fentanyl Citrate.
As of Nov 14, 2026, ANDA 207338 (Fentanyl Citrate), held by Actavis Labs Fl Inc, was first approved by FDA on Nov 17, 2017, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2017 | Original application | Approved |
| Fentanyl CitrateEQ 0.1MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.2MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.3MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.4MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.6MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.8MG BASE · tablet;sublingual | Fentanyl Citrate | Discontinued |
| Aug 28, 2024 | Supplement 10REMS | Approved | None posted |
| Dec 15, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 8, 2022 | Supplement 4REMS | Approved | None posted |
| Aug 17, 2022 | Supplement 3REMS | Approved | None posted |
| Dec 3, 2021 | Supplement 2REMS | Approved | None posted |
| Dec 23, 2020 | Supplement 1REMS | Approved | None posted |
| Nov 17, 2017 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
