Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020850
Company: BOEHRINGER INGELHEIM
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 |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020850s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020850Orig1s045ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020850s045lbl.pdf | |
| 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 |
| TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
| TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
| TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
| TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
| 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 | 207016 | MICRO LABS |
| 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 |
| 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 |
| TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
| TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
| TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
| TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
| 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 | 207016 | MICRO LABS |
| 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 |
| 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 |
| TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
| TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
| TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
| TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
| 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 | 207016 | MICRO LABS |
| 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 |
| TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 203325 | ZYDUS PHARMS |