Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 078633
Company: HIKMA

REMS

Products on ANDA 078633

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	Yes

Showing 1 to 2 of 2 entries

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078633

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
10/08/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.

Showing 1 to 1 of 1 entries

Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Note
02/21/2025	SUPPL-36	REMS - MODIFIED - D-N-A	Label is not available on this site.
03/20/2024	SUPPL-30	REMS - MODIFIED - D-N-A	Label is not available on this site.
12/15/2023	SUPPL-33	Labeling-Package Insert	Label is not available on this site.
10/18/2023	SUPPL-31	Labeling-Package Insert	Label is not available on this site.
12/16/2022	SUPPL-29	REMS - MODIFIED - D-N-A	Label is not available on this site.
06/17/2022	SUPPL-28	Labeling-Package Insert	Label is not available on this site.
06/17/2022	SUPPL-26	Labeling-Package Insert	Label is not available on this site.
05/03/2022	SUPPL-27	REMS - MODIFIED - D-N-A	Label is not available on this site.
11/24/2021	SUPPL-24	Labeling-Package Insert	Label is not available on this site.
03/04/2021	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert	Label is not available on this site.
02/08/2021	SUPPL-20	Labeling-Package Insert	Label is not available on this site.
10/07/2019	SUPPL-18	Labeling-Package Insert	Label is not available on this site.
10/31/2018	SUPPL-16	REMS - MODIFIED - D-N-A	Label is not available on this site.
02/01/2018	SUPPL-15	Labeling-Package Insert	Label is not available on this site.
05/23/2017	SUPPL-13	REMS-Modified	Label is not available on this site.
12/16/2016	SUPPL-12	Labeling-Package Insert	Label is not available on this site.
12/16/2016	SUPPL-11	Labeling-Package Insert	Label is not available on this site.
07/07/2016	SUPPL-10	REMS-Modified	Label is not available on this site.
02/12/2015	SUPPL-6	REMS-Modified	Label is not available on this site.
02/04/2015	SUPPL-7	Labeling-Package Insert	Label is not available on this site.
09/04/2013	SUPPL-5	REMS-Modified	Label is not available on this site.
02/22/2013	SUPPL-4	Labeling-Medication Guide, REMS-Proposal	Label is not available on this site.
02/21/2013	SUPPL-3	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert	Label is not available on this site.

Showing 1 to 23 of 23 entries

Therapeutic Equivalents for ANDA 078633

BUPRENORPHINE HYDROCHLORIDE

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

CSV Excel Print

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

Showing 1 to 6 of 6 entries

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

CSV Excel Print

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

Showing 1 to 6 of 6 entries