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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d9ba3859-90af-0390-11be-c04834e27d61	2025-05-16	Warnings	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Nephron Pharmaceuticals Corporation	f12043df-f9a3-4edb-88f8-dd176c1a141c	2025-04-09	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Major Pharmaceuticals	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Northstar Rx LLC.	a37866df-df07-4f71-8591-98c2804c4794	2025-02-18	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Zydus Pharmaceuticals USA Inc.	29863154-5f98-410e-9bf3-0f08b551edef	2025-02-12	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Zydus Lifesciences Limited	d645a346-c99b-4de7-9bca-69e73266d6b4	2025-02-12		Name fallback generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Preferred Pharmaceuticals Inc.	dcb35488-23c5-4e7b-ab86-8406cf855748	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	d406759d-4c02-4fc0-b513-56b303afca98	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Eohilia	BUDESONIDE	TAKEDA PHARMACEUTICALS AMERICA, INC.	56f2023a-69b2-4470-b4ad-af7ec1be527a	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	H2-Pharma LLC	10f2ae5b-a6fb-4804-9111-0cd067c2b1b2	2025-01-15	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Mylan Pharmaceuticals Inc.	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	2024-11-15	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Bryant Ranch Prepack	4943ef5b-f48b-49d6-b419-467f71ef64e0	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1	2024-10-25	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Uceris	BUDESONIDE	Santarus Inc.	92cbb190-8851-46ed-bfe0-166ca62ef2e9	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Amneal Pharmaceuticals LLC	b15102d5-7884-44ed-8340-046d7b516fa8	2024-09-19	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Actavis Pharma, Inc.	41d4fd39-81ee-41be-b34d-efb12b3a359d	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Padagis US LLC	3a18d5a7-04c5-4137-8155-70a8adc0a48b	2024-06-05	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	521a79d0-4d93-45f7-8feb-8d2b502dd216	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Chartwell RX, LLC	374013c9-18c9-4419-b9fb-9bc5c765688e	2024-02-02	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
BUDESONIDE	BUDESONIDE	Aurobindo Pharma Limited	c70c734f-2431-4414-bb94-4adda4985e5d	2023-12-02	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