Home Applications 207925 Application 207925
Type NDA
Sponsor VERTEX PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KALYDECO IVACAFTOR GRANULE;ORAL 50MG/PACKET Yes No 002 KALYDECO IVACAFTOR GRANULE;ORAL 75MG/PACKET Yes Yes 003 KALYDECO IVACAFTOR GRANULE;ORAL 25MG/PACKET Yes No 004 KALYDECO IVACAFTOR GRANULE;ORAL 5.8MG/PACKET Yes No 005 KALYDECO IVACAFTOR GRANULE;ORAL 13.4MG/PACKET Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207925-001 KALYDECO IVACAFTOR 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 N207925-002 KALYDECO IVACAFTOR 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 N207925-003 KALYDECO IVACAFTOR 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 N207925-004 KALYDECO IVACAFTOR 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 N207925-005 KALYDECO IVACAFTOR 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03
Orange Book patents# Current patent rows page 1 of 2 · 155 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 30 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 5 · 172 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 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 81 · 3,229 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 N207925-001 8354427 2026-07-06 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427 2026-07-06 U-2528 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427 2026-07-06 U-1905 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8410274 2026-12-28 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8754224 2026-12-28 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163 2026-12-28 U-1311 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163 2026-12-28 U-2530 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427*PED 2027-01-06 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 7495103 2027-05-20 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8410274*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8754224*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-1906 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-2527 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 7495103*PED 2027-11-20 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242*PED 2028-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10646481 2029-08-13 Drug product 2020-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11564916 2029-08-13 U-3528 2023-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12458635 2029-08-13 U-4337 Drug product 2025-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10646481*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11564916*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12458635*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10272046 2033-02-27 U-2531 Drug product 2019-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11147770 2033-02-27 U-3339 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11752106 2033-02-27 U-3697 Drug product 2023-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12214083 2033-02-27 U-4126 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8883206 2033-02-27 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10272046*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11147770*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11752106*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12214083*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8883206*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-1905 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-2528 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8410274 2026-12-28 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8754224 2026-12-28 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 9670163 2026-12-28 U-2530 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 9670163 2026-12-28 U-1311 Drug product 2017-07-05 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 24 · 921 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51167-300 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-300 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-300 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-300 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-300 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-400 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-400 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-400 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-400 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-400 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-600 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-600 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-600 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-600 Kalydeco ivacaftor Vertex Pharmaceuticals Incorporated NDA Current