Application 216579

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0048MG/INH	Yes	Yes
002	SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	AEROSOL, METERED;INHALATION	0.08MG/INH;0.0048MG/INH	Yes	Yes

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

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
N216579-001	SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2023-04-28
N216579-002	SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	0.08MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2026-04-27

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12
N216579-001	10716753	2030-05-28	U-4513	Drug product	2023-05-12
N216579-001	9415009	2030-05-28	U-3203		2023-05-12
N216579-001	9415009	2030-05-28	U-4513		2023-05-12
N216579-002	10716753	2030-05-28	U-4513	Drug product	2023-05-12
N216579-002	9415009	2030-05-28	U-4513		2023-05-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216579-001	I-988	2029-04-27
N216579-002	NS	2029-04-27

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.

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	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216579-001	SYMBICORT AEROSPHERE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2023-04-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216579-002	SYMBICORT AEROSPHERE	0.08MG/INH;0.0048MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-04-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 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	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216579-001	10716753	2030-05-28	U-3203	Drug product	2023-05-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216579-001	9415009	2030-05-28	U-3203		2023-05-12	`a67488948f0b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216579-001	I-988	2029-04-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216579-002	NS	2029-04-27	`a50c72e98297…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85790	SUPPL	2026-05-01
85789	SUPPL	2026-05-01
78074	ORIG	2024-04-05
74141	ORIG	2023-05-02