Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090279
Company: RUBICON

• REMS

Products on ANDA 090279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/26/2023	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/20/2024	SUPPL-21	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/16/2022	SUPPL-19	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/26/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/17/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/17/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/13/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/31/2018	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/01/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/23/2017	SUPPL-7	REMS-Modified		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/07/2016	SUPPL-4	REMS-Modified		Label is not available on this site.

Therapeutic Equivalents for ANDA 090279

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090819	ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090622	ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	078633	HIKMA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	207276	RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090279	RUBICON
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	201760	SUN PHARM

TABLET;SUBLINGUAL; EQ 8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090819	ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090622	ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	078633	HIKMA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	207276	RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090279	RUBICON
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	201760	SUN PHARM