Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020850
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICARDIS TELMISARTAN 40MG TABLET;ORAL Prescription AB Yes No
MICARDIS TELMISARTAN 80MG TABLET;ORAL Prescription AB Yes Yes
MICARDIS TELMISARTAN 20MG 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
11/10/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20850lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20850ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.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/2018/020850s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020850Orig1s040ltr.pdf
08/05/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/12/2014 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020850s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020850Orig1s038ltr.pdf
02/16/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/24/2012 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s036ltr.pdf
01/19/2012 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s035ltr.pdf
09/20/2012 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s033ltr.pdf
07/06/2011 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020850s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020850s032ltr.pdf
01/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s031ltr.pdf
10/16/2009 SUPPL-25 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s025ltr.pdf
08/11/2009 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf
08/11/2009 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf
02/27/2007 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020850s019ltr.pdf
09/02/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020850s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020850s013ltr.pdf
03/30/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020850s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20850slr011ltr.pdf
10/23/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20850slr005ltr.pdf
10/12/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/02/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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/2018/020850s040lbl.pdf
12/12/2014 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020850s038lbl.pdf
10/24/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s036lbl.pdf
09/20/2012 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf
01/19/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s035lbl.pdf
01/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s031lbl.pdf
07/06/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020850s032lbl.pdf
10/16/2009 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s025lbl.pdf
08/11/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf
08/11/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf
09/02/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020850s013lbl.pdf
03/30/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020850s011lbl.pdf
11/10/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20850lbl.pdf

MICARDIS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS TELMISARTAN 40MG TABLET;ORAL Prescription Yes AB 020850 BOEHRINGER INGELHEIM
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 202130 ALEMBIC PHARMS LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 090032 GLENMARK PHARMS LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 205901 HETERO LABS LTD V
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 205150 INVENTIA
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 204164 JUBILANT GENERICS
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 202397 MYLAN
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 207882 PRINSTON INC
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 203867 SANDOZ INC
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 203171 TORRENT
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS TELMISARTAN 80MG TABLET;ORAL Prescription Yes AB 020850 BOEHRINGER INGELHEIM
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 202130 ALEMBIC PHARMS LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 090032 GLENMARK PHARMS LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 205901 HETERO LABS LTD V
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 205150 INVENTIA
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 204164 JUBILANT GENERICS
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 202397 MYLAN
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 207882 PRINSTON INC
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 203867 SANDOZ INC
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 203171 TORRENT
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS TELMISARTAN 20MG TABLET;ORAL Prescription Yes AB 020850 BOEHRINGER INGELHEIM
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 202130 ALEMBIC PHARMS LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 090032 GLENMARK PHARMS LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 205901 HETERO LABS LTD V
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 205150 INVENTIA
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 204164 JUBILANT GENERICS
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 202397 MYLAN
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 207882 PRINSTON INC
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 203867 SANDOZ INC
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 203171 TORRENT
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS

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