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* Skip to main content * Skip to FDA Search * Skip to footer links An official website of the United States government Here's how you know The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials 1. Home 2. Drug Databases 3. Drugs@FDA DRUGS@FDA: FDA-APPROVED DRUGS * Share * Tweet * Linkedin * Email * Print Home | Previous Page New Drug Application (NDA): 020850 Company: BOEHRINGER INGELHEIM * Email * Other Important Information from FDA PRODUCTS ON NDA 020850 CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS 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 Showing 1 to 3 of 3 entries APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR NDA 020850 ORIGINAL APPROVALS OR TENTATIVE APPROVALS CSVExcelPrint Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan Status Letters, Reviews, Labels, Patient Package InsertNotes 11/10/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF) Letter (PDF) Review Showing 1 to 1 of 1 entries SUPPLEMENTS CSVExcelPrint Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package Insert Note 12/19/2022 SUPPL-45 Labeling-Package Insert Label (PDF) Letter (PDF) 02/01/2018 SUPPL-40 Labeling-Package Insert Label (PDF) Letter (PDF) 08/05/2015 SUPPL-39 Manufacturing (CMC) Label is not available on this site. 02/16/2015 SUPPL-37 Manufacturing (CMC) Label is not available on this site. 12/12/2014 SUPPL-38 Labeling-Package Insert Label (PDF) Letter (PDF) 10/24/2012 SUPPL-36 Labeling-Package Insert Label (PDF) Letter (PDF) 09/20/2012 SUPPL-33 Labeling-Package Insert Label (PDF) Letter (PDF) 01/19/2012 SUPPL-35 Labeling-Package Insert Label (PDF) Letter (PDF) 01/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF) Letter (PDF) 07/06/2011 SUPPL-32 Labeling-Package Insert Label (PDF) Letter (PDF) 10/16/2009 SUPPL-25 Efficacy-New Indication Label (PDF) Letter (PDF) 08/11/2009 SUPPL-23 Labeling Label (PDF) Letter (PDF) 08/11/2009 SUPPL-22 Labeling Label (PDF) Letter (PDF) 02/27/2007 SUPPL-19 Labeling Letter (PDF) Label is not available on this site. 09/02/2005 SUPPL-13 Labeling Label (PDF) Letter (PDF) 03/30/2004 SUPPL-11 Labeling Label (PDF) Letter (PDF) 10/23/2003 SUPPL-5 Labeling Letter (PDF) Label is not available on this site. 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. Showing 1 to 21 of 21 entries LABELS FOR NDA 020850 CSVExcelPrint Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNote 12/19/2022 SUPPL-45 Labeling-Package Insert Label (PDF) 02/01/2018 SUPPL-40 Labeling-Package Insert Label (PDF) 12/12/2014 SUPPL-38 Labeling-Package Insert Label (PDF) 10/24/2012 SUPPL-36 Labeling-Package Insert Label (PDF) 09/20/2012 SUPPL-33 Labeling-Package Insert Label (PDF) 01/19/2012 SUPPL-35 Labeling-Package Insert Label (PDF) 01/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF) 07/06/2011 SUPPL-32 Labeling-Package Insert Label (PDF) 10/16/2009 SUPPL-25 Efficacy-New Indication Label (PDF) 08/11/2009 SUPPL-23 Labeling Label (PDF) 08/11/2009 SUPPL-22 Labeling Label (PDF) 09/02/2005 SUPPL-13 Labeling Label (PDF) 03/30/2004 SUPPL-11 Labeling Label (PDF) 11/10/1998 ORIG-1 Approval Label (PDF) Showing 1 to 14 of 14 entries THERAPEUTIC EQUIVALENTS FOR NDA 020850 MICARDIS TABLET;ORAL; 40MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication 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 TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 078710 CELLTRION 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 INC TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS Showing 1 to 14 of 14 entries TABLET;ORAL; 80MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication 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 TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 078710 CELLTRION 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 INC TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS Showing 1 to 14 of 14 entries TABLET;ORAL; 20MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication 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 TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 078710 CELLTRION 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 INC TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 203325 ZYDUS PHARMS Showing 1 to 14 of 14 entries FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top