Orange Book product · Brand (NDA)
DURAGESIC-100
FENTANYL
At a glance
Aug 07, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 1990
36 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL
Strength
100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 019813
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2012SUBSYSBrand (NDA)
NDA 202788 · BTCP PHARMA
- 2023FENTANYL-100Generic (ANDA)
ANDA 209655 · ZYDUS PHARMS
- 2016FENTANYL-100Generic (ANDA)
ANDA 202097 · KINDEVA
- 2011FENTANYL-100Generic (ANDA)
ANDA 077154 · SPECGX LLC
- 2009FENTANYL-100Generic (ANDA)
ANDA 077775 · NOVEN
- 2008FENTANYL-100Generic (ANDA)
ANDA 077449 · DIFGEN PHARMS
- 2007FENTANYL-100Generic (ANDA)
ANDA 076709 · ACTAVIS LABS UT INC
- 2007FENTANYL-100Generic (ANDA)
ANDA 077062 · MAYNE PHARMA
- 2006FENTANYL-100Generic (ANDA)
ANDA 077051 · LAVIPHARM LABS
- 2005FENTANYL-100Generic (ANDA)
ANDA 076258 · MYLAN TECHNOLOGIES
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
