Orange Book product · Generic (ANDA)
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE
At a glance
Jan 30, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 30, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE HYDROCHLORIDE
Strength
EQ 0.3MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 219302
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUPRENORPHINE HYDROCHLORIDE
- 2016PROBUPHINEBrand (NDA)
NDA 204442 · REACX PHARMS
- 2015BELBUCABrand (NDA)
NDA 207932 · BDSI
- 2002SUBUTEXBrand (NDA)
NDA 020732 · INDIVIOR
- —BUPRENEXBrand (NDA)
NDA 018401 · INDIVIOR
- 2025BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219401 · ASCENT PHARMS INC
- 2025BUPRENORPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218473 · SPECGX 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.
