Application 210491

Type: NDA
Sponsor: VERTEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	TABLET, TABLET;ORAL	150MG,N/A;150MG, 100MG	Yes	Yes
002	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	TABLET, TABLET;ORAL	75MG,N/A;75MG, 50MG	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
N210491-001	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	150MG;150MG, 100MG	TABLET / ORAL		RLD, RS	2018-02-12
N210491-002	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	75MG;75MG, 50MG	TABLET / ORAL		RLD	2019-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 65 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210491-001	8354427	2026-07-06	U-3021		2021-01-14
N210491-001	8410274	2026-12-28		Drug product	2018-03-09
N210491-001	8754224	2026-12-28		Drug substance, Drug product	2018-03-09
N210491-001	9670163	2026-12-28	U-2246	Drug product	2018-03-09
N210491-001	9931334	2026-12-28	U-2275	Drug product	2018-05-01
N210491-001	9931334	2026-12-28	U-2575	Drug product	2018-05-01
N210491-001	10022352	2027-04-09	U-2343	Drug product	2018-08-08
N210491-001	10022352	2027-04-09	U-2573	Drug product	2018-08-08
N210491-001	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-04-19
N210491-001	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-04-19
N210491-001	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22
N210491-001	9974781	2027-04-09	U-2318	Drug product	2018-06-20
N210491-001	9974781	2027-04-09	U-2574	Drug product	2018-06-20
N210491-001	7645789	2027-05-01		Drug substance, Drug product	2018-03-09
N210491-001	8598181	2027-05-01	U-2246		2018-03-09
N210491-001	8623905	2027-05-01		Drug substance, Drug product	2018-03-09
N210491-001	7495103	2027-05-20		Drug substance, Drug product	2018-03-09
N210491-001	7776905	2027-06-03		Drug substance, Drug product	2018-03-09
N210491-001	8324242	2027-08-05	U-2246		2018-03-09
N210491-001	8415387	2027-11-12	U-2246		2018-03-09
N210491-001	10646481	2029-08-13		Drug product	2020-06-08
N210491-001	11564916	2029-08-13	U-3527		2023-02-28
N210491-001	12458635	2029-08-13	U-4336	Drug product	2025-11-26
N210491-001	10081621	2031-03-25	U-3024	Drug product	2018-10-25
N210491-001	10081621	2031-03-25	U-3025	Drug product	2018-10-25
N210491-001	11578062	2031-03-25	U-3545	Drug product	2023-03-16
N210491-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N210491-001	10058546	2033-07-15	U-3022		2018-09-21
N210491-001	10058546	2033-07-15	U-3023		2018-09-21
N210491-001	9012496	2033-07-15	U-2248		2018-03-09
N210491-001	10206877	2035-04-14	U-3026	Drug product	2019-03-20
N210491-001	10206877	2035-04-14	U-3027	Drug product	2019-03-20
N210491-001	11951212	2035-04-14	U-3894	Drug product	2024-05-02
N210491-002	8354427	2026-07-06	U-3021		2021-01-14
N210491-002	8410274	2026-12-28		Drug product	2019-07-17
N210491-002	8754224	2026-12-28		Drug substance, Drug product	2019-07-17
N210491-002	9670163	2026-12-28	U-2246	Drug product	2019-07-17
N210491-002	9931334	2026-12-28	U-2275	Drug product	2019-07-17
N210491-002	9931334	2026-12-28	U-2575	Drug product	2019-07-17
N210491-002	10022352	2027-04-09	U-2343	Drug product	2019-07-17
N210491-002	10022352	2027-04-09	U-2573	Drug product	2019-07-17
N210491-002	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-07-17
N210491-002	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-07-17
N210491-002	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22
N210491-002	9974781	2027-04-09	U-2318	Drug product	2019-07-17
N210491-002	9974781	2027-04-09	U-2574	Drug product	2019-07-17
N210491-002	7645789	2027-05-01		Drug substance, Drug product	2019-07-17
N210491-002	8598181	2027-05-01	U-2246		2019-07-17
N210491-002	8623905	2027-05-01		Drug substance, Drug product	2019-07-17
N210491-002	7495103	2027-05-20		Drug substance, Drug product	2019-07-17
N210491-002	7776905	2027-06-03		Drug substance, Drug product	2019-07-17
N210491-002	8324242	2027-08-05	U-2246		2019-07-17
N210491-002	8415387	2027-11-12	U-2246		2019-07-17
N210491-002	10646481	2029-08-13		Drug product	2020-06-08
N210491-002	11564916	2029-08-13	U-3527		2023-02-28
N210491-002	12458635	2029-08-13	U-4336	Drug product	2025-11-26
N210491-002	10081621	2031-03-25	U-3024	Drug product	2019-07-17
N210491-002	10081621	2031-03-25	U-3025	Drug product	2019-07-17
N210491-002	11578062	2031-03-25	U-3545	Drug product	2023-03-16
N210491-002	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N210491-002	10058546	2033-07-15	U-3022		2019-07-17
N210491-002	10058546	2033-07-15	U-3023		2019-07-17
N210491-002	9012496	2033-07-15	U-2248		2019-07-17
N210491-002	10206877	2035-04-14	U-3026	Drug product	2019-07-17
N210491-002	10206877	2035-04-14	U-3027	Drug product	2019-07-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210491-001	ODE-247	2026-06-21
N210491-001	ODE-335	2027-12-21
N210491-002	ODE-247	2026-06-21
N210491-002	ODE-335	2027-12-21

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 · 83 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210491-001	SYMDEKO (COPACKAGED)	150MG,N/A;150MG, 100MG	TABLET, TABLET / ORAL	RLD, RS	2018-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210491-002	SYMDEKO (COPACKAGED)	75MG,N/A;75MG, 50MG	TABLET, TABLET / ORAL	RLD, RS	2019-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 70 · 2,781 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	N210491-001	8354427	2026-07-06	U-3021		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8410274	2026-12-28		Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8754224	2026-12-28		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9670163	2026-12-28	U-2246	Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9931334	2026-12-28	U-2575	Drug product	2018-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9931334	2026-12-28	U-2275	Drug product	2018-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10022352	2027-04-09	U-2573	Drug product	2018-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10022352	2027-04-09	U-2343	Drug product	2018-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9974781	2027-04-09	U-2318	Drug product	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9974781	2027-04-09	U-2574	Drug product	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7645789	2027-05-01		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8598181	2027-05-01	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8623905	2027-05-01		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7495103	2027-05-20		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7776905	2027-06-03		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8324242	2027-08-05	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8415387	2027-11-12	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10646481	2029-08-13		Drug product	2020-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11564916	2029-08-13	U-3527		2023-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	12458635	2029-08-13	U-4336	Drug product	2025-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10081621	2031-03-25	U-3024	Drug product	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10081621	2031-03-25	U-3025	Drug product	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11578062	2031-03-25	U-3545	Drug product	2023-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10058546	2033-07-15	U-3023		2018-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10058546	2033-07-15	U-3022		2018-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9012496	2033-07-15	U-2248		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10206877	2035-04-14	U-3027	Drug product	2019-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10206877	2035-04-14	U-3026	Drug product	2019-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11951212	2035-04-14	U-3894	Drug product	2024-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8354427	2026-07-06	U-3021		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8410274	2026-12-28		Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8754224	2026-12-28		Drug substance, Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9670163	2026-12-28	U-2246	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9931334	2026-12-28	U-2575	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9931334	2026-12-28	U-2275	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	10022352	2027-04-09	U-2343	Drug product	2019-07-17	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 310 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N210491-001	ODE-247	2026-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	ODE-335	2027-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	ODE-247	2026-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	ODE-335	2027-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210491-001	ODE-247	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-001	ODE-335	2027-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	ODE-247	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	ODE-335	2027-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-173	2025-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-247	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-335	2027-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-173	2025-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-247	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-335	2027-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-173	2025-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-247	2026-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-335	2027-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-173	2025-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-247	2026-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-335	2027-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-173	2025-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-247	2026-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-335	2027-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-173	2025-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-247	2026-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-335	2027-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-173	2025-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-247	2026-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-335	2027-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-173	2025-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-247	2026-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-335	2027-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-173	2025-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-247	2026-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-335	2027-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-173	2025-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-247	2026-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-335	2027-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	ODE-173	2025-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	ODE-247	2026-06-21	`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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SYMDEKO	TEZACAFTOR AND IVACAFTOR	Vertex Pharmaceuticals Incorporated	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210491 application number: NDA210491 ndc (product): 51167-113 ndc (product): 51167-661

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85469	SUPPL	2026-03-24
83568	SUPPL	2025-09-26
83540	SUPPL	2025-09-26
74996	SUPPL	2023-08-04
65744	SUPPL	2020-12-28
65710	SUPPL	2020-12-23
61505	SUPPL	2020-01-02
61470	SUPPL	2019-12-30
59177	SUPPL	2019-06-27
59163	SUPPL	2019-06-24
52945	ORIG	2018-03-13
52602	ORIG	2018-02-13
52601	ORIG	2018-02-13