ANDA 78907, held by Specgx LLC. Fentanyl Citrate.
As of Nov 14, 2026, ANDA 78907 (Fentanyl Citrate), held by Specgx LLC, was first approved by FDA on Oct 30, 2009, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2009 | Original application | Approved |
| Fentanyl CitrateEQ 0.2MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.4MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.6MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.8MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 1.2MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 1.6MG BASE · troche/lozenge;transmucosal | Fentanyl Citrate | Discontinued |
| Dec 8, 2022 | Supplement 25REMS | Approved | None posted |
| Aug 17, 2022 | Supplement 24REMS | Approved | None posted |
| Dec 3, 2021 | Supplement 22REMS | Approved | None posted |
| Dec 23, 2020 | Supplement 17REMS | Approved | None posted |
| Sep 7, 2017 | Supplement 16REMS | Approved | None posted |
| Apr 24, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 24, 2014 | Supplement 12REMS | Approved | None posted |
| Nov 7, 2013 | Supplement 11REMS | Approved | None posted |
| Jun 8, 2012 | Supplement 9Labeling | Approved | None posted |
| Jan 4, 2012 | Supplement 8Labeling | Approved | None posted |
| Jan 4, 2012 | Supplement 7REMS | Approved | None posted |
| Oct 30, 2009 | 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
