Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020186
Company: TEVA BRANDED PHARM
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 |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020186s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020186Orig1s042ltr.pdf | |
| 03/02/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020186s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020186Orig1s037ltr.pdf | |
| 08/20/2020 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020186s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020186Orig1s035ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020186s042lbl.pdf | |
| 03/02/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020186s037lbl.pdf | |
| 08/20/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020186s035lbl.pdf | |
| 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 | 217922 | AUROBINDO PHARMA LTD |
| 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 |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 219489 | UNIQUE PHARM |
| 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 | 217922 | AUROBINDO PHARMA LTD |
| 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 |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 219489 | UNIQUE PHARM |
| 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 | 217922 | AUROBINDO PHARMA LTD |
| 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 |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 219489 | UNIQUE PHARM |
| ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |