Application 021949

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PULMICORT FLEXHALER	BUDESONIDE	POWDER, METERED;INHALATION	0.08MG/INH	Yes	No
002	PULMICORT FLEXHALER	BUDESONIDE	POWDER, METERED;INHALATION	0.16MG/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021949-001	PULMICORT FLEXHALER	BUDESONIDE	0.08MG/INH	POWDER, METERED / INHALATION		RLD, RS	2006-07-12
N021949-002	PULMICORT FLEXHALER	BUDESONIDE	0.16MG/INH	POWDER, METERED / INHALATION		RLD, RS	2006-07-12

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`3a93d1ddd44b…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	Rubicon Holdings Inc.	ae1105cd-69fc-4c15-937f-c535304341c2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	H2-Pharma LLC	10f2ae5b-a6fb-4804-9111-0cd067c2b1b2	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	10ea5d87-6ed0-4fa5-a37b-2043c8560bc0	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	79fc8cf4-bb33-4892-9dd2-641d7e943a01	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949 ndc (product): 50090-2239

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0916	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0917	PULMICORT	Budesonide	AstraZeneca Pharmaceuticals LP	NDA	Current
21695-291	PULMICORT	Budesonide	Rebel Distributors Corp	NDA	Current
50090-2239	PULMICORT	Budesonide	A-S Medication Solutions	NDA	Current
50090-2239	PULMICORT	Budesonide	A-S Medication Solutions	NDA	Current
50090-2239	PULMICORT	Budesonide	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59949	SUPPL	2019-09-10
59939	SUPPL	2019-09-09
6528	SUPPL	2010-07-08
16633	SUPPL	2010-07-06
42356	ORIG	2008-11-17
6527	SUPPL	2008-06-19
37940	SUPPL	2008-06-18
16632	SUPPL	2008-04-16
6526	SUPPL	2008-04-16
6525	SUPPL	2007-07-05
16631	SUPPL	2007-06-27
16630	SUPPL	2007-02-23
6524	SUPPL	2007-02-23
6523	ORIG	2006-07-21
37939	ORIG	2006-07-13