Home Applications 020850 Application 020850
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MICARDIS TELMISARTAN TABLET;ORAL 40MG Yes No 002 MICARDIS TELMISARTAN TABLET;ORAL 80MG Yes Yes 003 MICARDIS TELMISARTAN TABLET;ORAL 20MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020850-001 MICARDIS TELMISARTAN 40MG TABLET / ORAL RLD 1998-11-10 N020850-002 MICARDIS TELMISARTAN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-11-10 N020850-003 MICARDIS TELMISARTAN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N020850-001 MICARDIS 40MG TABLET / ORAL RLD 1998-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020850-002 MICARDIS 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020850-003 MICARDIS 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020850-001 MICARDIS 40MG TABLET / ORAL RLD 1998-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020850-002 MICARDIS 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020850-003 MICARDIS 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020850-003 MICARDIS 20MG TABLET / ORAL RLD 2000-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-003 MICARDIS 20MG TABLET / ORAL RLD 2000-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD 1998-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 3 of 3 · 42 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-0542 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0054-0542 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0054-0543 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0054-0543 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0054-0544 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0054-0544 Telmisartan telmisartan West-Ward Pharmaceuticals Corp. NDA AUTHORIZED GENERIC Current 0597-0039 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0039 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0039 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0039 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0040 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0040 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0040 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0040 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0041 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0041 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0041 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0041 Micardis telmisartan Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current