Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020186
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET;ORAL Prescription AB Yes No
ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET;ORAL Prescription AB Yes Yes
ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/26/1993 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/03/2011 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

05/03/2011 SUPPL-27 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020186s027s028lbl.pdf
11/06/2009 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020186s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020186s026ltr.pdf
09/25/2007 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020186s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf
01/24/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf
04/04/2000 SUPPL-11 Labeling

Label is not available on this site.

06/22/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-8 Labeling

Label is not available on this site.

01/15/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1996 SUPPL-5 Labeling

Label is not available on this site.

05/30/1995 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf
04/15/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1993 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2011 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020186s027s028lbl.pdf
11/06/2009 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020186s026lbl.pdf
09/25/2007 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020186s023lbl.pdf

ZIAC

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 075768 MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET;ORAL Prescription No AB 075579 SANDOZ
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 075768 MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET;ORAL Prescription No AB 075579 SANDOZ
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

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 075768 MYLAN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET;ORAL Prescription No AB 075579 SANDOZ
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

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