Orange Book product · Generic (ANDA)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
At a glance
Sep 08, 2014
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 08, 2014
11 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
TE code
Not listed
Application
ANDA 091149
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- 2018CASSIPABrand (NDA)
NDA 208042 · TEVA PHARMS USA
- 2016ZUBSOLVBrand (NDA)
NDA 204242 · EDENBRIDGE PHARMS
- 2014BUNAVAILBrand (NDA)
NDA 205637 · BDSI
- 2010SUBOXONEBrand (NDA)
NDA 022410 · INDIVIOR
- 2002SUBOXONEBrand (NDA)
NDA 020733 · INDIVIOR
- 2026BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 219850 · ASCENT PHARMS INC
- 2025BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 219727 · ASCENT PHARMS INC
- 2025BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212756 · DIFGEN PHARMS
- 2021BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 214930 · ALKEM LABS LTD
- 2020BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 206953 · DR REDDYS LABS SA
- 2020BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 209069 · WES PHARMA INC
- 2020BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 211785 · MYLAN TECHNOLOGIES
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.
