Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021162
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
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
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 PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
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 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 091648 MYLAN
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 201192 TORRENT
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 PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
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 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 091648 MYLAN
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 201192 TORRENT
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 PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
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 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 091648 MYLAN
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 201192 TORRENT
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 204221 ZYDUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English