Orange Book product · Brand (NDA)
CASSIPA
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
At a glance
Sep 07, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 07, 2018
7 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Strength
EQ 16MG BASE;EQ 4MG BASE
Dosage form
FILM
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 208042
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.
- 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
- 2020BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEGeneric (ANDA)
ANDA 205601 · RHODES PHARMS
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.
