Orange Book product · Generic (ANDA)
BUPRENORPHINE
BUPRENORPHINE
At a glance
May 17, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 17, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE
Strength
5MCG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB
Application
ANDA 207490
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
- 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.
