Application 020441

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PULMICORT	BUDESONIDE	POWDER, METERED;INHALATION	0.16MG/INH	No	No
003	PULMICORT	BUDESONIDE	POWDER, METERED;INHALATION	0.32MG/INH	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020441-002	PULMICORT	BUDESONIDE	0.16MG/INH	POWDER, METERED / INHALATION			1997-06-24
N020441-003	PULMICORT	BUDESONIDE	0.32MG/INH	POWDER, METERED / INHALATION			1997-06-24

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020441-002	PULMICORT	0.16MG/INH	POWDER, METERED / INHALATION	1997-06-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020441-003	PULMICORT	0.32MG/INH	POWDER, METERED / INHALATION	1997-06-24	`74a2ff9319b5…`

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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	A-S Medication Solutions	32e30f11-e19b-4e23-a893-92d95e48edef	2023-11-29	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	10ea5d87-6ed0-4fa5-a37b-2043c8560bc0	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2b	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
BUDESONIDE	BUDESONIDE	Padagis Israel Pharmaceuticals Ltd	ad4a68e7-9200-4f05-8058-714d5d8900f8	2023-04-17	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	79fc8cf4-bb33-4892-9dd2-641d7e943a01	2023-02-04	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73	2021-10-01	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	4f126a29-38f7-4c4c-8978-37e72b289902	2021-01-12	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	2414058b-5d39-42f2-915f-03a5e1101ab5	2021-01-12	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Exelan Pharmaceuticals, Inc.	d9656442-4587-4867-9a8c-5f5b0402936e	2020-12-11	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Uceris	BUDESONIDE	Salix Pharmaceuticals, Inc.	230e4596-2a9b-4d55-b0a0-0cabbcff5289	2020-04-23	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	d90ffda1-12c7-4726-90e9-64bb103e84b5	2019-10-31	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT RESPULES	BUDESONIDE	AstraZeneca Pharmaceuticals LP	33cd9834-76df-4f26-3fa2-aab6b9eee8f2	2019-10-11	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41363	SUPPL	2007-11-19
41362	SUPPL	2007-11-19
41361	SUPPL	2007-11-19
41360	SUPPL	2007-11-19
20659	SUPPL	2007-11-19
20658	SUPPL	2007-11-19
20657	SUPPL	2007-11-19
20656	SUPPL	2007-11-19
20655	SUPPL	2007-11-19
24969	SUPPL	2007-08-22
12580	SUPPL	2007-08-21
41365	SUPPL	2007-07-09
41364	SUPPL	2007-07-09
41366	SUPPL	2007-07-06
20660	SUPPL	2007-04-11
34652	SUPPL	2003-12-29
24968	SUPPL	2003-12-22
34651	SUPPL	2003-11-05
24967	SUPPL	2003-11-05
34653	SUPPL	2003-09-30
2536	SUPPL	2003-09-30
2535	SUPPL	2001-12-31
41359	SUPPL	1998-10-08
34650	SUPPL	1998-10-08
24966	SUPPL	1998-10-08