Orange Book product · Brand (NDA)
BUTRANS
BUPRENORPHINE
At a glance
Jun 30, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 30, 2010
16 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE
Strength
5MCG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB
Application
NDA 021306
Product number
001
Marketing status
RX
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.
- 2023BRIXADIBrand (NDA)
NDA 210136 · BRAEBURN
- 2017SUBLOCADEBrand (NDA)
NDA 209819 · INDIVIOR
- 2022BUPRENORPHINEGeneric (ANDA)
ANDA 207490 · STRIDES PHARMA INTL
- 2021BUPRENORPHINEGeneric (ANDA)
ANDA 210272 · DIFGEN PHARMS
- 2021BUPRENORPHINEGeneric (ANDA)
ANDA 210162 · MYLAN TECH VIATRIS
- 2020BUPRENORPHINEGeneric (ANDA)
ANDA 211586 · AMNEAL
- 2018BUPRENORPHINEGeneric (ANDA)
ANDA 204937 · WATSON LABS TEVA
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.
