Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091149
Company: TEVA PHARMS USA

• REMS

Products on ANDA 091149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET;SUBLINGUAL	Discontinued	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET;SUBLINGUAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091149

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2014	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-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2023	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/20/2024	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/16/2022	SUPPL-21	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/17/2022	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-19	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/17/2022	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/13/2022	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2018	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/01/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/01/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/31/2018	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/23/2017	SUPPL-9	REMS-Modified		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/07/2016	SUPPL-3	REMS-Modified		Label is not available on this site.
02/05/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/12/2015	SUPPL-1	REMS-Modified		Label is not available on this site.