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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202097
Company: KINDEVA
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
11/04/2016 ORIG-1 Approval Not Applicable

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-4 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-1 REMS-Modified

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
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 202097 KINDEVA
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
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 202097 KINDEVA
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
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 202097 KINDEVA
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
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 202097 KINDEVA
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
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 202097 KINDEVA
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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