Application 207356

Type: NDA
Sponsor: INSMED INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIKAYCE KIT	AMIKACIN SULFATE	SUSPENSION, LIPOSOMAL;INHALATION	EQ 590MG BASE/8.4ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207356-001	ARIKAYCE KIT	AMIKACIN SULFATE	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION		RLD, RS	2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207356-001	8632804	2026-12-05	U-2416		2018-10-24
N207356-001	8642075	2026-12-05		Drug product	2018-10-24
N207356-001	8679532	2026-12-05	U-2415		2018-10-24
N207356-001	8226975	2028-08-15		Drug product	2018-10-24
N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24
N207356-001	10251900	2035-05-15	U-2414		2019-05-02
N207356-001	10751355	2035-05-15	U-2414		2020-09-24
N207356-001	11446318	2035-05-15	U-2414		2022-10-14
N207356-001	12016873	2035-05-15	U-2414		2024-07-22
N207356-001	12168021	2035-05-15	U-2414		2025-01-15
N207356-001	12168022	2035-05-15	U-2414		2025-01-15
N207356-001	12377114	2035-05-15	U-2414		2025-08-20
N207356-001	12616708	2035-05-15	U-2414		2026-05-26
N207356-001	9895385	2035-05-15	U-2417		2018-10-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207356-001	ODE-214	2025-09-28
N207356-001	GAIN	2030-09-28

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 486 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12377114	2035-05-15	U-2414		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	7718189	2025-06-06	U-2415	Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12377114	2035-05-15	U-2414		2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	7718189	2025-06-06	U-2415	Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	ODE-214	2025-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	GAIN	2030-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	ODE-214	2025-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	GAIN	2030-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	ODE-214	2025-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	GAIN	2030-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	ODE-214	2025-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	GAIN	2030-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	ODE-214	2025-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	GAIN	2030-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	ODE-214	2025-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	GAIN	2030-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	ODE-214	2025-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	GAIN	2030-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	ODE-214	2025-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	GAIN	2030-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	ODE-214	2025-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	GAIN	2030-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207356-001	ODE-214	2025-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207356-001	GAIN	2030-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	ODE-214	2025-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	GAIN	2030-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	ODE-214	2025-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	GAIN	2030-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	ODE-214	2025-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	GAIN	2030-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207356-001	ODE-214	2025-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207356-001	GAIN	2030-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	ODE-214	2025-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	GAIN	2030-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207356-001	ODE-214	2025-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207356-001	GAIN	2030-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207356-001	ODE-214	2025-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207356-001	GAIN	2030-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207356-001	ODE-214	2025-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207356-001	GAIN	2030-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207356-001	ODE-214	2025-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207356-001	GAIN	2030-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207356-001	ODE-214	2025-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207356-001	GAIN	2030-09-28	`782e0a99824c…`

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
ARIKAYCE	AMIKACIN	Insmed Incorporated	499ab990-2b21-474f-aaba-d86388965f40	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207356 application number: NDA207356 ndc (product): 71558-590

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current
71558-590	ARIKAYCE	Amikacin	Insmed Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84405	SUPPL	2025-12-15
84367	SUPPL	2025-12-09
74619	SUPPL	2023-06-23
74425	SUPPL	2023-06-02
73475	SUPPL	2023-02-13
73467	SUPPL	2023-02-13
64964	SUPPL	2020-10-21
62157	SUPPL	2020-03-17
62147	SUPPL	2020-03-16
62146	SUPPL	2020-03-16
58788	ORIG	2019-05-20
55859	ORIG	2018-10-10
55673	ORIG	2018-09-28