Application 020746

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RHINOCORT	BUDESONIDE	SPRAY, METERED;NASAL	0.032MG/INH	Yes	No
002	RHINOCORT	BUDESONIDE	SPRAY, METERED;NASAL	0.064MG/INH	No	No
003	RHINOCORT ALLERGY	BUDESONIDE	SPRAY, METERED;NASAL	0.032MG/SPRAY	Yes	Yes

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

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
N020746-003	RHINOCORT ALLERGY	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-03-23

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020746-003	RHINOCORT ALLERGY	0.032MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2015-03-23	`f41ea6bd6efb…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-510	Childrens RHINOCORT Allergy	Budesonide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-646	RHINOCORT Allergy	budesonide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-646	RHINOCORT Allergy	budesonide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-646	RHINOCORT Allergy	budesonide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-646	RHINOCORT Allergy	budesonide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48535	SUPPL	2017-05-25
48523	SUPPL	2017-05-25
45066	SUPPL	2016-08-29
45177	SUPPL	2016-08-24
35265	SUPPL	2016-05-03
25685	SUPPL	2016-04-25
35264	SUPPL	2016-03-15
3254	SUPPL	2016-03-14
25684	SUPPL	2015-03-25
13334	SUPPL	2015-03-25
25683	SUPPL	2011-01-04
13333	SUPPL	2010-12-28
3253	SUPPL	2009-05-29
13332	SUPPL	2009-05-25
13331	SUPPL	2007-10-22
3252	SUPPL	2007-10-22
35263	SUPPL	2004-08-31
25682	SUPPL	2004-08-31
3251	SUPPL	2004-08-02
41640	ORIG	2004-06-16
35262	SUPPL	2004-01-22
3250	SUPPL	2004-01-22
13330	SUPPL	2003-09-30
25681	SUPPL	2003-09-26
25680	SUPPL	2001-10-26
35261	ORIG	1999-10-01
25679	ORIG	1999-10-01