Orange Book product · Brand (NDA)
SUBUTEX
BUPRENORPHINE HYDROCHLORIDE
At a glance
Oct 08, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 08, 2002
24 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE HYDROCHLORIDE
Strength
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 020732
Product number
002
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
- —BUPRENEXBrand (NDA)
NDA 018401 · 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.
