Application 021929

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	AEROSOL, METERED;INHALATION	0.08MG/INH;0.0045MG/INH	Yes	Yes
002	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0045MG/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
N021929-001	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21
N021929-002	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021929-001	AB
N021929-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021929-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021929-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021929-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021929-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021929-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021929-002	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021929-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021929-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021929-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021929-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021929-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021929-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021929-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021929-002	AB	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 41 · 1,620 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	7587988	2026-04-10	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8387615	2027-03-26	Drug product	2013-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8387615*PED	2027-09-26	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8528545	2028-10-16	Drug product	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8616196	2029-04-07	Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8528545*PED	2029-04-16	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8616196*PED	2029-10-07	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8875699*PED	2025-05-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	7587988	2026-04-10	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	7587988*PED	2026-10-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8387615	2027-03-26	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8387615*PED	2027-09-26	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8528545	2028-10-16	Drug product	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8616196	2029-04-07	Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8528545*PED	2029-04-16	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8616196*PED	2029-10-07	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	7587988	2026-04-10	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8387615	2027-03-26	Drug product	2013-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8387615*PED	2027-09-26	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8528545	2028-10-16	Drug product	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8616196	2029-04-07	Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8528545*PED	2029-04-16	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8616196*PED	2029-10-07	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8875699*PED	2025-05-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	7587988	2026-04-10	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	7587988*PED	2026-10-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8387615	2027-03-26	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8387615*PED	2027-09-26	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8528545	2028-10-16	Drug product	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8616196	2029-04-07	Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8528545*PED	2029-04-16	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8616196*PED	2029-10-07	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	8875699	2024-11-10	Drug product	2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	7587988	2026-04-10	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021929-001	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	M-210	2020-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	M-210	2020-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	M-214	2020-12-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021929-001	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	M-210	2020-09-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-002	M-210	2020-09-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-002	M-214	2020-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021929-001	NPP	2020-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	PED	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	M-210	2020-09-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-002	M-210	2020-09-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-002	M-214	2020-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021929-001	NPP	2020-01-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	PED	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	M-210	2020-09-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-002	M-210	2020-09-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-002	M-214	2020-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021929-001	NPP	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	PED	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	M-210	2020-09-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-002	M-210	2020-09-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-002	M-214	2020-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021929-001	NPP	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	PED	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	M-210	2020-09-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	M-214	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-002	M-210	2020-09-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-002	M-214	2020-12-20	`ea99ee380514…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	Sportpharm LLC	d6cc66c9-6f97-4ea8-a787-30a048004c77	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	Sportpharm LLC	a645756c-c692-4bc6-a858-7e7e249561bd	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	6b78d08a-e098-4188-8f7f-94fbd5f396ef	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929 ndc (product): 50090-1403
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	b974bab9-c6d2-41ad-b930-28f2904c5f9d	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	805764a1-65e1-4117-ac4a-7a54c3986cfe	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	5feb8f35-b237-477a-9836-2a6db2ed6fa7	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	52f45e18-463e-4ce3-8ccd-c0260473e6b5	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	AstraZeneca Pharmaceuticals LP	fafa4cf1-99c2-43d5-73ad-51f256de3be0	2019-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929 ndc (product): 0186-0370 ndc (product): 0186-0372
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	AstraZeneca Pharmaceuticals LP	1d266fe8-52e3-4f85-a037-c5c1afa15e60	2019-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929 ndc (product): 0310-7370 ndc (product): 0310-7372

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0370	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0370	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0370	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0372	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0372	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0372	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7370	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7370	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7370	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7372	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7372	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7372	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
50090-1403	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	A-S Medication Solutions	NDA	Current
53002-2666	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
53002-2667	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70518-2696	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	REMEDYREPACK INC.	NDA	Current
70518-3107	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3107	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3107	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3107	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50926	SUPPL	2017-12-27
50829	SUPPL	2017-12-21
49749	SUPPL	2017-09-15
49721	SUPPL	2017-09-12
49720	SUPPL	2017-09-12
47047	SUPPL	2017-01-31
47032	SUPPL	2017-01-27
51270	SUPPL	2015-10-19
51269	SUPPL	2015-03-09
28877	SUPPL	2012-07-25
51268	SUPPL	2012-04-06
42353	SUPPL	2012-03-02
6488	SUPPL	2011-08-22
51267	SUPPL	2011-05-05
28875	SUPPL	2011-02-18
51266	SUPPL	2011-01-28
28876	SUPPL	2010-06-29
16601	SUPPL	2010-06-28
16600	SUPPL	2009-04-03
6487	SUPPL	2009-03-03
42352	ORIG	2008-10-30
28874	SUPPL	2008-07-17
16599	SUPPL	2008-07-16
28873	SUPPL	2007-11-08
6486	SUPPL	2007-11-08
37905	SUPPL	2007-11-07
16598	SUPPL	2007-11-07
23686	ORIG	2007-02-21
37904	ORIG	2006-07-21
6485	ORIG	2006-07-21
52069	SUPPL	1900-01-01
52067	SUPPL	1900-01-01
52065	SUPPL	1900-01-01