Orange Book product · Brand (NDA)
BUPRENEX
BUPRENORPHINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BUPRENORPHINE HYDROCHLORIDE
Strength
EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018401
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.
- 2016PROBUPHINEBrand (NDA)
NDA 204442 · REACX PHARMS
- 2015BELBUCABrand (NDA)
NDA 207932 · BDSI
- 2002SUBUTEXBrand (NDA)
NDA 020732 · INDIVIOR
- 2025BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219401 · ASCENT PHARMS INC
- 2025BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218473 · SPECGX LLC
- 2025BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219302 · SOMERSET THERAPS LLC
- 2017BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207276 · RHODES PHARMS
- 2016BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201760 · SUN PHARM
- 2015BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206586 · PH HEALTH
- 2015BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090279 · RUBICON RESEARCH
- 2015BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201066 · PHARMOBEDIENT
- 2015BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090819 · ACTAVIS ELIZABETH
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.
