Home Applications 217660 Application 217660
Type NDA
Sponsor VERTEX PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR GRANULE;ORAL 80MG, 60MG, 40MG;59.5MG Yes No 002 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR GRANULE;ORAL 100MG, 75MG, 50MG;75MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N217660-001 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 80MG, 60MG, 40MG;59.5MG GRANULE / ORAL RLD 2023-04-26 N217660-002 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 100MG, 75MG, 50MG;75MG GRANULE / ORAL RLD, RS 2023-04-26
Orange Book patents# Current patent rows page 1 of 2 · 148 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217660-001 8354427 2026-07-06 U-3593 2023-05-24 N217660-001 8410274 2026-12-28 Drug product 2023-05-24 N217660-001 8754224 2026-12-28 Drug substance, Drug product 2023-05-24 N217660-001 9670163 2026-12-28 U-3591 Drug product 2023-05-24 N217660-001 9670163 2026-12-28 U-4068 Drug product 2023-05-24 N217660-001 9670163 2026-12-28 U-4478 Drug product 2023-05-24 N217660-001 9931334 2026-12-28 U-3591 Drug product 2023-05-24 N217660-001 9931334 2026-12-28 U-4068 Drug product 2023-05-24 N217660-001 9931334 2026-12-28 U-4478 Drug product 2023-05-24 N217660-001 10022352 2027-04-09 U-3596 Drug product 2023-05-24 N217660-001 10239867 2027-04-09 U-3590 Drug substance, Drug product 2023-05-24 N217660-001 10239867 2027-04-09 U-4053 Drug substance, Drug product 2023-05-24 N217660-001 10239867 2027-04-09 U-4476 Drug substance, Drug product 2023-05-24 N217660-001 11639347 2027-04-09 U-3583 Drug substance, Drug product 2023-05-24 N217660-001 11639347 2027-04-09 U-4053 Drug substance, Drug product 2023-05-24 N217660-001 11639347 2027-04-09 U-4476 Drug substance, Drug product 2023-05-24 N217660-001 9974781 2027-04-09 U-3589 Drug product 2023-05-24 N217660-001 9974781 2027-04-09 U-4066 Drug product 2023-05-24 N217660-001 9974781 2027-04-09 U-4476 Drug product 2023-05-24 N217660-001 7645789 2027-05-01 Drug substance, Drug product 2023-05-24 N217660-001 8598181 2027-05-01 U-3589 2023-05-24 N217660-001 8598181 2027-05-01 U-4066 2023-05-24 N217660-001 8598181 2027-05-01 U-4476 2023-05-24 N217660-001 8623905 2027-05-01 Drug substance, Drug product 2023-05-24 N217660-001 7495103 2027-05-20 Drug substance, Drug product 2023-05-24 N217660-001 7776905 2027-06-03 Drug substance, Drug product 2023-05-24 N217660-001 8324242 2027-08-05 U-3589 2023-05-24 N217660-001 8324242 2027-08-05 U-4066 2023-05-24 N217660-001 8324242 2027-08-05 U-4476 2023-05-24 N217660-001 8415387 2027-11-12 U-3589 2023-05-24 N217660-001 8415387 2027-11-12 U-4066 2023-05-24 N217660-001 8415387 2027-11-12 U-4476 2023-05-24 N217660-001 10646481 2029-08-13 Drug product 2023-05-24 N217660-001 11564916 2029-08-13 U-3585 2023-05-24 N217660-001 11564916 2029-08-13 U-4055 2023-05-24 N217660-001 11564916 2029-08-13 U-4485 2023-05-24 N217660-001 12458635 2029-08-13 U-4333 Drug product 2025-11-21 N217660-001 12458635 2029-08-13 U-4493 Drug product 2025-11-21 N217660-001 10081621 2031-03-25 U-3600 Drug product 2023-05-24 N217660-001 10081621 2031-03-25 U-4065 Drug product 2023-05-24 N217660-001 10081621 2031-03-25 U-4481 Drug product 2023-05-24 N217660-001 11578062 2031-03-25 U-3584 Drug product 2023-05-24 N217660-001 11578062 2031-03-25 U-4054 Drug product 2023-05-24 N217660-001 11578062 2031-03-25 U-4488 Drug product 2023-05-24 N217660-001 RE50453 2031-07-10 Drug substance, Drug product 2025-07-11 N217660-001 10272046 2033-02-27 U-3599 Drug product 2023-05-24 N217660-001 10272046 2033-02-27 U-4062 Drug product 2023-05-24 N217660-001 10272046 2033-02-27 U-4482 Drug product 2023-05-24 N217660-001 11147770 2033-02-27 U-3598 Drug product 2023-05-24 N217660-001 11147770 2033-02-27 U-4060 Drug product 2023-05-24 N217660-001 11147770 2033-02-27 U-4483 Drug product 2023-05-24 N217660-001 11752106 2033-02-27 U-3696 Drug product 2023-10-11 N217660-001 11752106 2033-02-27 U-4052 Drug product 2023-10-11 N217660-001 11752106 2033-02-27 U-4489 Drug product 2023-10-11 N217660-001 12214083 2033-02-27 U-4141 Drug product 2025-03-03 N217660-001 12214083 2033-02-27 U-4492 Drug product 2025-03-03 N217660-001 8883206 2033-02-27 Drug product 2023-05-24 N217660-001 10758534 2035-10-06 U-3589 Drug substance, Drug product 2023-05-24 N217660-001 10758534 2035-10-06 U-4066 Drug substance, Drug product 2023-05-24 N217660-001 10758534 2035-10-06 U-4476 Drug substance, Drug product 2023-05-24 N217660-001 11426407 2035-10-06 U-3595 Drug substance, Drug product 2023-05-24 N217660-001 11426407 2035-10-06 U-4058 Drug substance, Drug product 2023-05-24 N217660-001 11426407 2035-10-06 U-4476 Drug substance, Drug product 2023-05-24 N217660-001 10793547 2037-12-08 U-3588 Drug substance, Drug product 2023-05-24 N217660-001 10793547 2037-12-08 U-4066 Drug substance, Drug product 2023-05-24 N217660-001 10793547 2037-12-08 U-4476 Drug substance, Drug product 2023-05-24 N217660-001 11179367 2037-12-08 U-3597 Drug product 2023-05-24 N217660-001 11179367 2037-12-08 U-4059 Drug product 2023-05-24 N217660-001 11179367 2037-12-08 U-4484 Drug product 2023-05-24 N217660-001 11453655 2037-12-08 Drug substance, Drug product 2023-05-24 N217660-001 11517564 2037-12-08 U-3586 Drug product 2023-05-24 N217660-001 11517564 2037-12-08 U-4057 Drug product 2023-05-24 N217660-001 11517564 2037-12-08 U-4476 Drug product 2023-05-24 N217660-002 8354427 2026-07-06 U-3593 2023-05-24 N217660-002 8410274 2026-12-28 Drug product 2023-05-24 N217660-002 8754224 2026-12-28 Drug substance, Drug product 2023-05-24 N217660-002 9670163 2026-12-28 U-3591 Drug product 2023-05-24 N217660-002 9670163 2026-12-28 U-4068 Drug product 2023-05-24 N217660-002 9670163 2026-12-28 U-4478 Drug product 2023-05-24 N217660-002 9931334 2026-12-28 U-3591 Drug product 2023-05-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 9 matching rows.
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 2 · 46 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 2026-08-18 06:07:40 2026-07 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULE / ORAL RLD 2023-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULE / ORAL RLD, RS 2023-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217660-001 TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG GRANULES / ORAL RLD 2023-04-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217660-002 TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG GRANULES / ORAL RLD, RS 2023-04-26 9b2671bbb829…
Observed Orange Book patent history# Patent history page 1 of 46 · 1,811 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217660-001 8354427 2026-07-06 U-3593 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8410274 2026-12-28 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8754224 2026-12-28 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9670163 2026-12-28 U-4068 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9670163 2026-12-28 U-3591 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9670163 2026-12-28 U-4478 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9931334 2026-12-28 U-4068 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9931334 2026-12-28 U-3591 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9931334 2026-12-28 U-4478 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10022352 2027-04-09 U-3596 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10239867 2027-04-09 U-3590 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10239867 2027-04-09 U-4053 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10239867 2027-04-09 U-4476 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11639347 2027-04-09 U-3583 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11639347 2027-04-09 U-4053 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11639347 2027-04-09 U-4476 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9974781 2027-04-09 U-4066 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9974781 2027-04-09 U-3589 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 9974781 2027-04-09 U-4476 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 7645789 2027-05-01 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8598181 2027-05-01 U-4066 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8598181 2027-05-01 U-3589 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8598181 2027-05-01 U-4476 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8623905 2027-05-01 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 7495103 2027-05-20 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 7776905 2027-06-03 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8324242 2027-08-05 U-4066 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8324242 2027-08-05 U-3589 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8324242 2027-08-05 U-4476 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8415387 2027-11-12 U-3589 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8415387 2027-11-12 U-4066 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 8415387 2027-11-12 U-4476 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10646481 2029-08-13 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11564916 2029-08-13 U-3585 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11564916 2029-08-13 U-4055 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 11564916 2029-08-13 U-4485 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 12458635 2029-08-13 U-4333 Drug product 2025-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 12458635 2029-08-13 U-4493 Drug product 2025-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10081621 2031-03-25 U-4065 Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217660-001 10081621 2031-03-25 U-3600 Drug product 2023-05-24 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 142 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trikafta ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR Vertex Pharmaceuticals Incorporated f354423a-85c2-41c3-a9db-0f3aee135d8d 2026-06-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 217660 application number: NDA217660
Documents# Document, Submission type, Date table Document Submission type Date 85897 SUPPL 2026-05-13 85660 SUPPL 2026-04-09 85584 SUPPL 2026-03-30 85479 SUPPL 2026-03-24 85417 SUPPL 2026-03-19 81652 SUPPL 2025-07-25 81650 SUPPL 2025-07-25 81649 SUPPL 2025-07-25 81648 SUPPL 2025-07-25 76516 ORIG 2023-11-07 74998 SUPPL 2023-08-04 74984 SUPPL 2023-08-04 74098 ORIG 2023-04-27 74090 ORIG 2023-04-27