Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076258
Company: MYLAN TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None No No
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-87 FENTANYL 87.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription 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
01/28/2005 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-37 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-35 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-33 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-32 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-31 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-30 REMS-Modified

Label is not available on this site.

06/20/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

07/08/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-22 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/09/2012 SUPPL-19 REMS-Proposal

Label is not available on this site.

07/10/2012 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/20/2008 SUPPL-10 Labeling

Label is not available on this site.

09/06/2005 SUPPL-7 Labeling

Label is not available on this site.

01/23/2007 SUPPL-6 Labeling

Label is not available on this site.

01/23/2007 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/04/2005 SUPPL-2 Labeling

Label is not available on this site.

FENTANYL-100

FILM, EXTENDED RELEASE;TRANSDERMAL; 100MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077062 MAYNE PHARMA
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

FENTANYL-12

FILM, EXTENDED RELEASE;TRANSDERMAL; 12.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

FENTANYL-25

FILM, EXTENDED RELEASE;TRANSDERMAL; 25MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077062 MAYNE PHARMA
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

FENTANYL-37

FILM, EXTENDED RELEASE;TRANSDERMAL; 37.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES

FENTANYL-50

FILM, EXTENDED RELEASE;TRANSDERMAL; 50MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077062 MAYNE PHARMA
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

FENTANYL-62

There are no Therapeutic Equivalents.

FENTANYL-75

FILM, EXTENDED RELEASE;TRANSDERMAL; 75MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077062 MAYNE PHARMA
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

FENTANYL-87

There are no Therapeutic Equivalents.

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