Home Applications 212273 Application 212273
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 TABLET, TABLET;ORAL 100MG,75MG,50MG;N/A,150MG,N/A Yes Yes 002 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TABLET;ORAL 50MG,37.5MG,25MG; 75MG Yes No
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 N212273-001 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 N212273-002 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08
Orange Book patents# Current patent rows page 1 of 2 · 141 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212273-001 8354427 2026-07-06 U-3029 2019-11-14 N212273-001 8354427 2026-07-06 U-3145 2019-11-14 N212273-001 8410274 2026-12-28 Drug product 2019-11-14 N212273-001 8754224 2026-12-28 Drug substance, Drug product 2019-11-14 N212273-001 9670163 2026-12-28 U-3031 Drug product 2019-11-14 N212273-001 9670163 2026-12-28 U-3155 Drug product 2019-11-14 N212273-001 9670163 2026-12-28 U-4078 Drug product 2019-11-14 N212273-001 9670163 2026-12-28 U-4477 Drug product 2019-11-14 N212273-001 9931334 2026-12-28 U-3031 Drug product 2019-11-14 N212273-001 9931334 2026-12-28 U-3155 Drug product 2019-11-14 N212273-001 9931334 2026-12-28 U-4078 Drug product 2019-11-14 N212273-001 9931334 2026-12-28 U-4479 Drug product 2019-11-14 N212273-001 10022352 2027-04-09 U-2651 Drug product 2019-11-14 N212273-001 10022352 2027-04-09 U-3156 Drug product 2019-11-14 N212273-001 10239867 2027-04-09 U-3033 Drug substance, Drug product 2019-11-14 N212273-001 10239867 2027-04-09 U-3158 Drug substance, Drug product 2019-11-14 N212273-001 10239867 2027-04-09 U-4056 Drug substance, Drug product 2019-11-14 N212273-001 10239867 2027-04-09 U-4475 Drug substance, Drug product 2019-11-14 N212273-001 11639347 2027-04-09 U-3587 Drug substance, Drug product 2023-05-24 N212273-001 11639347 2027-04-09 U-4056 Drug substance, Drug product 2023-05-24 N212273-001 11639347 2027-04-09 U-4475 Drug substance, Drug product 2023-05-24 N212273-001 9974781 2027-04-09 U-3028 Drug product 2019-11-14 N212273-001 9974781 2027-04-09 U-3144 Drug product 2019-11-14 N212273-001 9974781 2027-04-09 U-4073 Drug product 2019-11-14 N212273-001 9974781 2027-04-09 U-4475 Drug product 2019-11-14 N212273-001 7645789 2027-05-01 Drug substance, Drug product 2019-11-14 N212273-001 8598181 2027-05-01 U-3028 2019-11-14 N212273-001 8598181 2027-05-01 U-3144 2019-11-14 N212273-001 8598181 2027-05-01 U-4056 2019-11-14 N212273-001 8598181 2027-05-01 U-4475 2019-11-14 N212273-001 8623905 2027-05-01 Drug substance, Drug product 2019-11-14 N212273-001 7495103 2027-05-20 Drug substance, Drug product 2019-11-14 N212273-001 7776905 2027-06-03 Drug substance, Drug product 2019-11-14 N212273-001 8324242 2027-08-05 U-3028 2019-11-14 N212273-001 8324242 2027-08-05 U-3144 2019-11-14 N212273-001 8324242 2027-08-05 U-4073 2019-11-14 N212273-001 8324242 2027-08-05 U-4475 2019-11-14 N212273-001 8415387 2027-11-12 U-3028 2019-11-14 N212273-001 8415387 2027-11-12 U-3144 2019-11-14 N212273-001 8415387 2027-11-12 U-4073 2019-11-14 N212273-001 8415387 2027-11-12 U-4475 2019-11-14 N212273-001 10646481 2029-08-13 Drug product 2020-06-08 N212273-001 11564916 2029-08-13 U-3525 2023-02-28 N212273-001 11564916 2029-08-13 U-4063 2023-02-28 N212273-001 11564916 2029-08-13 U-4491 2023-02-28 N212273-001 12458635 2029-08-13 U-4330 Drug product 2025-11-21 N212273-001 12458635 2029-08-13 U-4486 Drug product 2025-11-21 N212273-001 10081621 2031-03-25 U-3032 Drug product 2019-11-14 N212273-001 10081621 2031-03-25 U-3157 Drug product 2019-11-14 N212273-001 10081621 2031-03-25 U-4075 Drug product 2019-11-14 N212273-001 10081621 2031-03-25 U-4480 Drug product 2019-11-14 N212273-001 11578062 2031-03-25 U-3544 Drug product 2023-03-15 N212273-001 11578062 2031-03-25 U-4054 Drug product 2023-03-15 N212273-001 11578062 2031-03-25 U-4490 Drug product 2023-03-15 N212273-001 RE50453 2031-07-10 Drug substance, Drug product 2025-07-11 N212273-001 9012496 2033-07-15 U-2649 2019-11-14 N212273-001 9012496 2033-07-15 U-3154 2019-11-14 N212273-001 10758534 2035-10-06 U-3028 Drug substance, Drug product 2020-09-22 N212273-001 10758534 2035-10-06 U-3144 Drug substance, Drug product 2020-09-22 N212273-001 10758534 2035-10-06 U-4073 Drug substance, Drug product 2020-09-22 N212273-001 10758534 2035-10-06 U-4475 Drug substance, Drug product 2020-09-22 N212273-001 11426407 2035-10-06 U-3425 Drug substance, Drug product 2022-09-26 N212273-001 11426407 2035-10-06 U-4070 Drug substance, Drug product 2022-09-26 N212273-001 11426407 2035-10-06 U-4475 Drug substance, Drug product 2022-09-26 N212273-001 10793547 2037-12-08 U-3028 Drug substance, Drug product 2020-10-29 N212273-001 10793547 2037-12-08 U-3144 Drug substance, Drug product 2020-10-29 N212273-001 10793547 2037-12-08 U-4073 Drug substance, Drug product 2020-10-29 N212273-001 10793547 2037-12-08 U-4475 Drug substance, Drug product 2020-10-29 N212273-001 11179367 2037-12-08 U-3253 Drug product 2021-12-14 N212273-001 11179367 2037-12-08 U-4071 Drug product 2021-12-14 N212273-001 11179367 2037-12-08 U-4487 Drug product 2021-12-14 N212273-001 11453655 2037-12-08 Drug substance, Drug product 2022-10-21 N212273-001 11517564 2037-12-08 U-3498 Drug product 2023-01-05 N212273-001 11517564 2037-12-08 U-4067 Drug product 2023-01-05 N212273-001 11517564 2037-12-08 U-4475 Drug product 2023-01-05 N212273-001 12350262 2038-07-17 U-4221 2025-07-30 N212273-001 12350262 2038-07-17 U-4475 2025-07-30 N212273-002 8354427 2026-07-06 U-3145 2021-06-29 N212273-002 8410274 2026-12-28 Drug product 2021-06-29 N212273-002 8754224 2026-12-28 Drug substance, Drug product 2021-06-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 · 74 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 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG;N/A,150MG,N/A TABLET, TABLET / ORAL RLD, RS 2019-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212273-002 TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG TABLET / ORAL RLD 2021-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212273-001 TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG TABLET / ORAL RLD, RS 2019-10-21 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 76 · 3,003 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 N212273-001 8354427 2026-07-06 U-3029 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8354427 2026-07-06 U-3145 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8410274 2026-12-28 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8754224 2026-12-28 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9670163 2026-12-28 U-4078 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9670163 2026-12-28 U-3031 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9670163 2026-12-28 U-3155 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9670163 2026-12-28 U-4477 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9931334 2026-12-28 U-4078 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9931334 2026-12-28 U-3031 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9931334 2026-12-28 U-3155 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9931334 2026-12-28 U-4479 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10022352 2027-04-09 U-2651 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10022352 2027-04-09 U-3156 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10239867 2027-04-09 U-3158 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10239867 2027-04-09 U-4056 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10239867 2027-04-09 U-3033 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 10239867 2027-04-09 U-4475 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 11639347 2027-04-09 U-3587 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 11639347 2027-04-09 U-4056 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 11639347 2027-04-09 U-4475 Drug substance, Drug product 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9974781 2027-04-09 U-3028 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9974781 2027-04-09 U-3144 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9974781 2027-04-09 U-4073 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 9974781 2027-04-09 U-4475 Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 7645789 2027-05-01 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8598181 2027-05-01 U-3028 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8598181 2027-05-01 U-3144 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8598181 2027-05-01 U-4056 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8598181 2027-05-01 U-4475 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8623905 2027-05-01 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 7495103 2027-05-20 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 7776905 2027-06-03 Drug substance, Drug product 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8324242 2027-08-05 U-4073 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8324242 2027-08-05 U-3028 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8324242 2027-08-05 U-3144 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8324242 2027-08-05 U-4475 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8415387 2027-11-12 U-4073 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8415387 2027-11-12 U-3028 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212273-001 8415387 2027-11-12 U-3144 2019-11-14 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 9 · 329 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): 212273 application number: NDA212273 ndc (product): 51167-106 ndc (product): 51167-331
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51167-106 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-106 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-106 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-331 Trikafta Elexacaftor, Tezacaftor, and Ivacaftor Vertex Pharmaceuticals Incorporated NDA Current