Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077775
Company: NOVEN
Company: NOVEN
| 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2009 | 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 |
|---|---|---|---|---|---|
| 04/20/2016 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-19 | REMS-Proposal |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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| 07/03/2014 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-11 | REMS-Proposal |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
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| 02/17/2011 | SUPPL-6 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |