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 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.

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