Application 206038

Type: NDA
Sponsor: VERTEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORKAMBI	IVACAFTOR; LUMACAFTOR	TABLET;ORAL	125MG;200MG	Yes	Yes
002	ORKAMBI	IVACAFTOR; LUMACAFTOR	TABLET;ORAL	125MG;100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N206038-001	ORKAMBI	IVACAFTOR; LUMACAFTOR	125MG;200MG	TABLET / ORAL		RLD, RS	2015-07-02
N206038-002	ORKAMBI	IVACAFTOR; LUMACAFTOR	125MG;100MG	TABLET / ORAL		RLD	2016-09-28

Orange Book patents#

Current patent rows page 2 of 2 · 94 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206038-002	11564916	2029-08-13	U-3529		2023-02-28
N206038-002	12458635	2029-08-13	U-4338	Drug product	2025-11-26
N206038-002	9192606	2029-09-29	U-1912	Drug product	2016-10-21
N206038-002	8846718*PED	2030-01-02		Pediatric extension
N206038-002	10646481*PED	2030-02-13		Pediatric extension
N206038-002	11564916*PED	2030-02-13		Pediatric extension
N206038-002	12458635*PED	2030-02-13		Pediatric extension
N206038-002	9192606*PED	2030-03-29		Pediatric extension
N206038-002	8507534	2030-09-20		Drug substance, Drug product	2016-10-21
N206038-002	8716338	2030-09-20	U-1910	Drug product	2016-10-21
N206038-002	8993600	2030-12-11		Drug product	2016-10-21
N206038-002	8507534*PED	2031-03-20		Pediatric extension
N206038-002	8716338*PED	2031-03-20		Pediatric extension
N206038-002	8993600*PED	2031-06-11		Pediatric extension

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206038-001	ORKAMBI	125MG;200MG	TABLET / ORAL	RLD, RS	2015-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206038-002	ORKAMBI	125MG;100MG	TABLET / ORAL	RLD	2016-09-28	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 58 · 2,306 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206038-001	7973038	2026-11-08	U-1973		2016-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8741933	2026-11-08	U-1909		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8741933	2026-11-08	U-1717		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9216969	2026-11-08		Drug substance, Drug product	2016-03-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8410274	2026-12-28		Drug product	2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8754224	2026-12-28		Drug substance, Drug product	2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9670163	2026-12-28	U-1911	Drug product	2017-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9931334	2026-12-28	U-2276	Drug product	2018-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	7973038*PED	2027-05-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8741933*PED	2027-05-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9216969*PED	2027-05-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	7495103	2027-05-20		Drug substance, Drug product	2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8410274*PED	2027-06-28		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8754224*PED	2027-06-28		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9670163*PED	2027-06-28		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9931334*PED	2027-06-28		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8324242	2027-08-05	U-1311		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8324242	2027-08-05	U-1911		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	7495103*PED	2027-11-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8324242*PED	2028-02-05		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10076513	2028-12-04	U-2411	Drug product	2018-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10597384	2028-12-04	U-2777	Drug substance, Drug product	2020-04-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	11052075	2028-12-04	U-3181	Drug product	2021-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	12065432	2028-12-04	U-3984		2024-09-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8653103	2028-12-04		Drug product	2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9150552	2028-12-04	U-1908		2016-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10076513*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10597384*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	11052075*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	12065432*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8653103*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9150552*PED	2029-06-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8846718	2029-07-02	U-1717		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8846718	2029-07-02	U-1908		2015-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10646481	2029-08-13		Drug product	2020-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	11564916	2029-08-13	U-3529		2023-02-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	12458635	2029-08-13	U-4338	Drug product	2025-11-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	9192606	2029-09-29	U-1912	Drug product	2016-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	8846718*PED	2030-01-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206038-001	10646481*PED	2030-02-13		Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-001	ODE-93	2022-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-001	ODE-123	2023-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-002	ODE-93	2022-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206038-002	ODE-123	2023-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206038-001	ODE-93	2022-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206038-001	ODE-123	2023-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206038-002	ODE-93	2022-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206038-002	ODE-123	2023-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206038-001	ODE-93	2022-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206038-001	ODE-123	2023-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206038-002	ODE-93	2022-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206038-002	ODE-123	2023-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206038-001	NCE	2020-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-001	M-218	2021-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-001	ODE-93	2022-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-001	ODE-123	2023-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-002	NPP	2019-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-002	NCE	2020-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-002	M-218	2021-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-002	ODE-93	2022-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206038-002	ODE-123	2023-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206038-001	ODE-93	2022-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206038-001	ODE-123	2023-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206038-002	ODE-93	2022-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206038-002	ODE-123	2023-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206038-001	M-218	2021-01-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206038-001	ODE-93	2022-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206038-001	ODE-123	2023-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206038-002	M-218	2021-01-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206038-002	ODE-93	2022-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206038-002	ODE-123	2023-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-001	M-218	2021-01-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-001	ODE-93	2022-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-001	ODE-123	2023-09-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-002	M-218	2021-01-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-002	ODE-93	2022-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206038-002	ODE-123	2023-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206038-001	M-218	2021-01-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206038-001	ODE-93	2022-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206038-001	ODE-123	2023-09-28	`5aa47cf7b7d7…`

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
ORKAMBI	LUMACAFTOR AND IVACAFTOR	Vertex Pharmaceuticals Incorporated	3fc1c40e-cfac-47a1-9e1a-61ead3570600	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206038 application number: NDA206038 ndc (product): 51167-809 ndc (product): 51167-700

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85475	SUPPL	2026-03-24
85411	SUPPL	2026-03-19
83564	SUPPL	2025-09-26
83552	SUPPL	2025-09-26
80594	SUPPL	2024-12-16
80580	SUPPL	2024-12-16
74994	SUPPL	2023-08-04
74987	SUPPL	2023-08-04
72036	SUPPL	2022-09-07
72017	SUPPL	2022-09-06
55211	SUPPL	2018-08-20
55192	SUPPL	2018-08-17
52425	SUPPL	2018-02-06
52097	SUPPL	2018-01-30
47284	SUPPL	2017-02-22
45500	SUPPL	2016-09-30
45277	SUPPL	2016-09-07
40522	SUPPL	2016-05-20
10540	SUPPL	2016-05-20
24509	ORIG	2015-08-07
23011	ORIG	2015-08-07
19701	ORIG	2015-07-02
10539	ORIG	2015-07-02