Home Applications 022081 Application 022081
Type NDA
Sponsor GILEAD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LETAIRIS AMBRISENTAN TABLET;ORAL 5MG Yes No 002 LETAIRIS AMBRISENTAN TABLET;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022081-001 LETAIRIS AMBRISENTAN 5MG TABLET / ORAL AB RLD 2007-06-15 N022081-002 LETAIRIS AMBRISENTAN 10MG TABLET / ORAL AB RLD, RS 2007-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022081-001 8377933 2027-12-11 U-1754 2015-10-23 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 N022081-002 9549926 2031-10-14 U-1965 2017-02-16
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 2680178bc6a6…
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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-0801 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current 61958-0801 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current 61958-0801 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current 61958-0802 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current 61958-0802 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current 61958-0802 Letairis AMBRISENTAN Gilead Sciences, Inc NDA Current