An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079106
Company: UNICHEM

Products on ANDA 079106

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	AB	No	No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	AB	No	No
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079106

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2010	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
03/01/2024	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
12/01/2022	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/29/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079106

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 2.5MG;6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215666	CADILA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	212678	EDENBRIDGE PHARMS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075579	EPIC PHARMA LLC
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215995	GLENMARK PHARMS LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075768	MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215562	NOVITIUM PHARMA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	079106	UNICHEM
ZIAC	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET;ORAL	Prescription	Yes	AB	020186	TEVA BRANDED PHARM

TABLET;ORAL; 5MG;6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215666	CADILA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	212678	EDENBRIDGE PHARMS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075579	EPIC PHARMA LLC
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215995	GLENMARK PHARMS LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075768	MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215562	NOVITIUM PHARMA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	079106	UNICHEM
ZIAC	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	Yes	AB	020186	TEVA BRANDED PHARM

TABLET;ORAL; 10MG;6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215666	CADILA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	212678	EDENBRIDGE PHARMS
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075579	EPIC PHARMA LLC
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215995	GLENMARK PHARMS LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	075768	MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	215562	NOVITIUM PHARMA
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	No	AB	079106	UNICHEM
ZIAC	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET;ORAL	Prescription	Yes	AB	020186	TEVA BRANDED PHARM

Top