ANDA 79075, held by Watson Labs. Fentanyl Citrate.
As of Nov 14, 2026, ANDA 79075 (Fentanyl Citrate), held by Watson Labs, was first approved by FDA on Jan 7, 2011, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2011 | Original application | Approved |
| Fentanyl CitrateEQ 0.1MG BASE · tablet;buccal, sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.2MG BASE · tablet;buccal, sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.4MG BASE · tablet;buccal, sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.6MG BASE · tablet;buccal, sublingual | Fentanyl Citrate | Discontinued |
| Fentanyl CitrateEQ 0.8MG BASE · tablet;buccal, sublingual | Fentanyl Citrate | Discontinued |
| Aug 28, 2024 | Supplement 18REMS | Approved | None posted |
| Dec 8, 2022 | Supplement 17REMS | Approved | None posted |
| Aug 17, 2022 | Supplement 16REMS | Approved | None posted |
| Dec 3, 2021 | Supplement 15REMS | Approved | None posted |
| Dec 23, 2020 | Supplement 14REMS | Approved | None posted |
| Sep 7, 2017 | Supplement 13REMS | Approved | None posted |
| Apr 12, 2017 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jan 8, 2016 | Supplement 10REMS | Approved | None posted |
| Jan 8, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 3, 2015 | Supplement 2Labeling | Approved | None posted |
| May 3, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 7, 2011 | 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
