Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077154
Company: SPECGX LLC
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-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
FENTANYL-75 FENTANYL 75MCG/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
02/09/2011 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-20 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-17 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-16 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-12 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-11 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-10 REMS-Modified

Label is not available on this site.

06/16/2014 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-6 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/09/2012 SUPPL-3 REMS-Proposal

Label is not available on this site.

06/11/2015 SUPPL-2 Manufacturing (CMC)-New Strength

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-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-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

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