Application 211922

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	0.25MG/2ML	No	No
002	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	0.5MG/2ML	No	No
003	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	1MG/2ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211922-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14
A211922-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14
A211922-003	BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211922-001	AN
A211922-002	AN
A211922-003	AN

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 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211922-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2021-04-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211922-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211922-002	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211922-003	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211922-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211922-002	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211922-003	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-002	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211922-003	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211922-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211922-002	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211922-003	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-002	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211922-003	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211922-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211922-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211922-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211922-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211922-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211922-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211922-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211922-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211922-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211922-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211922-001	AN	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	American Health Packaging	c7df2a10-4166-423e-bb60-5f3a8234f26c	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211922 application number: ANDA211922
Budesonide	BUDESONIDE	Sun Pharmaceutical Industries, Inc.	a39fbcfc-3ffd-44bd-b882-01f8e1844213	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211922 application number: ANDA211922 ndc (product): 47335-633 ndc (product): 47335-632 ndc (product): 47335-631
Budesonide	BUDESONIDE	A-S Medication Solutions	d406759d-4c02-4fc0-b513-56b303afca98	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211922 application number: ANDA211922
Budesonide	BUDESONIDE	A-S Medication Solutions	4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2b	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211922 application number: ANDA211922

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-631	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-631	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-632	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-632	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-633	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-633	Budesonide	Budesonide	Sun Pharmaceutical Industries, Inc.	ANDA	Current