Application 205710

Type: ANDA
Sponsor: CIPLA

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
A205710-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16
A205710-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16
A205710-003	BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205710-001	AN
A205710-002	AN
A205710-003	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 4 · 126 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	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A205710-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-002	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-003	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205710-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-002	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-003	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-002	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-003	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205710-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-002	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-003	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-002	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-003	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205710-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205710-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide Inhalation Suspension	BUDESONIDE	Cipla USA Inc.	c52c5382-1400-44b9-95be-a30e1cf706da	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710 ndc (product): 69097-318 ndc (product): 69097-321 ndc (product): 69097-319
Budesonide Inhalation Suspension	BUDESONIDE	Preferred Pharmaceuticals Inc.	dcb35488-23c5-4e7b-ab86-8406cf855748	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710 ndc (product): 68788-7314
Budesonide Inhalation Suspension	BUDESONIDE	Exelan Pharmaceuticals, Inc.	d9656442-4587-4867-9a8c-5f5b0402936e	2020-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710 ndc (product): 76282-640 ndc (product): 76282-641 ndc (product): 76282-642

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-018	Budesonide	Budesonide	NorthStar RxLLC	ANDA	Current
16714-019	Budesonide	Budesonide	NorthStar RxLLC	ANDA	Current
16714-020	Budesonide	Budesonide	NorthStar RxLLC	ANDA	Current
60687-645	Budesonide	Budesonide	American Health Packaging	ANDA	Current
68788-7290	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7290	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7290	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7290	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7314	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7314	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7314	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7314	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-318	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-319	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
69097-321	Budesonide	Budesonide	Cipla USA Inc.	ANDA	Current
76282-640	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-640	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-640	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-640	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-641	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-641	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-641	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-641	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-642	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-642	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-642	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-642	Budesonide	Budesonide	Exelan Pharmaceuticals, Inc.	ANDA	Current