Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077775
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.

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.

02/17/2011 SUPPL-6 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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