Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078907
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/30/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078907s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/17/2022 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/03/2021 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/23/2020 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 09/07/2017 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
| 04/24/2017 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2014 | SUPPL-12 | REMS-Modified |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
||
| 06/08/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2012 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2012 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |