Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077062
Company: MAYNE PHARMA
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-38 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-36 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-34 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-29 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-27 REMS-Modified

Label is not available on this site.

12/21/2014 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

08/19/2014 SUPPL-24 REMS-Modified

Label is not available on this site.

06/24/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-19 REMS-Modified, Labeling-Package Insert

Label is not available on this site.

08/31/2012 SUPPL-18 REMS-Proposal

Label is not available on this site.

07/09/2012 SUPPL-13 REMS-Proposal

Label is not available on this site.

07/07/2009 SUPPL-5 Labeling

Label is not available on this site.

01/07/2008 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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