ANDA 77312, held by Par Pharm. Fentanyl Citrate.
As of Nov 14, 2026, ANDA 77312 (Fentanyl Citrate), held by Par Pharm, was first approved by FDA on Oct 30, 2009, with 8 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 |
| Sep 7, 2017 | Supplement 9REMS | Approved | None posted |
| Apr 14, 2017 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 24, 2014 | Supplement 6REMS | Approved | None posted |
| Nov 7, 2013 | Supplement 5REMS | Approved | None posted |
| Jun 29, 2012 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 8, 2012 | Supplement 3Labeling | Approved | None posted |
| Jan 20, 2012 | Supplement 1Labeling | Approved | None posted |
| Dec 28, 2011 | Supplement 2Labeling | 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
