Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076709
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/20/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-31 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-28 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-26 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-25 | REMS-Modified |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-24 | REMS-Modified |
Label is not available on this site. |
||
| 06/20/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
||
| 07/27/2012 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/02/2011 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-12 | REMS-Proposal |
Label is not available on this site. |
||
| 12/17/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |