Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077449
Company: AVEVA
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 AB 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 AB 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
10/20/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077449Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-26 REMS - MODIFIED - D-N-A

Label is not available on this site.

08/10/2017 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-24 REMS-Modified

Label is not available on this site.

08/10/2017 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-20 REMS - MODIFIED - D-N-A

Label is not available on this site.

08/22/2016 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-18 REMS-Modified

Label is not available on this site.

09/11/2015 SUPPL-16

Label is not available on this site.

06/26/2015 SUPPL-15 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-11 REMS-Modified

Label is not available on this site.

07/23/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/19/2013 SUPPL-5 REMS-Modified

Label is not available on this site.

03/07/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/14/2013 SUPPL-3 REMS-Proposal

Label is not available on this site.

03/02/2009 SUPPL-1 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

FILM, EXTENDED RELEASE;TRANSDERMAL; 62.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA

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

FILM, EXTENDED RELEASE;TRANSDERMAL; 87.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENTANYL-87 FENTANYL 87.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA

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