Orange Book product · Generic (ANDA)
BUPRENORPHINE
BUPRENORPHINE
At a glance
Nov 20, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2018
7 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE
Strength
5MCG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB
Application
ANDA 204937
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUPRENORPHINE
- 2023BRIXADIBrand (NDA)
NDA 210136 · BRAEBURN
- 2017SUBLOCADEBrand (NDA)
NDA 209819 · INDIVIOR
- 2010BUTRANSBrand (NDA)
NDA 021306 · KNOA PHARMA
- 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
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.
