Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021162
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | AB | Yes | No |
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/17/2000 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21162ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-162_Micards.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/19/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021162s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021162Orig1s047ltr.pdf | |
08/20/2020 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021162s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021162Orig1s045ltr.pdf | |
02/01/2018 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021162s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021162Orig1s040ltr.pdf | |
12/12/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021162Orig1s037ltr.pdf | |
10/24/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162Orig1s035ltr.pdf | |
01/19/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s034ltr.pdf | |
01/12/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021162Orig1s032ltr.pdf | |
05/12/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf | |
01/20/2012 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s030ltr.pdf | |
05/12/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf | |
08/11/2009 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf | |
08/11/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf | |
02/27/2007 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021162s016ltr.pdf |
09/02/2005 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021162s008ltr.pdf | |
04/19/2004 | SUPPL-5 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21162scm005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/19/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021162s047lbl.pdf | |
08/20/2020 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021162s045lbl.pdf | |
02/01/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021162s040lbl.pdf | |
01/12/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf | |
12/12/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf | |
10/24/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf | |
01/20/2012 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf | |
01/19/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf | |
05/12/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf | |
05/12/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf | |
08/11/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf | |
08/11/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf | |
09/02/2005 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf | |
11/17/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf |
MICARDIS HCT
TABLET;ORAL; 12.5MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |
TABLET;ORAL; 12.5MG;80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |
TABLET;ORAL; 25MG;80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |