Application 201966

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	1MG/2ML	No	No
002	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	0.5MG/2ML	No	No
003	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	0.25MG/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	Approval date
A201966-001	BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	2013-09-27
A201966-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	2013-09-27
A201966-003	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	2013-09-27

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	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201966-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-002	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-003	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201966-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201966-002	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201966-003	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-003	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201966-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201966-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201966-003	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201966-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201966-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201966-003	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201966-001	AN	1	`74a2ff9319b5…`

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 brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Nephron Pharmaceuticals Corporation	f12043df-f9a3-4edb-88f8-dd176c1a141c	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Major Pharmaceuticals	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Northstar Rx LLC.	a37866df-df07-4f71-8591-98c2804c4794	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Zydus Pharmaceuticals USA Inc.	29863154-5f98-410e-9bf3-0f08b551edef	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Zydus Lifesciences Limited	d645a346-c99b-4de7-9bca-69e73266d6b4	2025-02-12		Name fallback brand name: budesonide 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 brand name: Budesonide 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 brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Bryant Ranch Prepack	4943ef5b-f48b-49d6-b419-467f71ef64e0	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: budesonide 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 brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Actavis Pharma, Inc.	41d4fd39-81ee-41be-b34d-efb12b3a359d	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Padagis US LLC	3a18d5a7-04c5-4137-8155-70a8adc0a48b	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	521a79d0-4d93-45f7-8feb-8d2b502dd216	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Chartwell RX, LLC	374013c9-18c9-4419-b9fb-9bc5c765688e	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
BUDESONIDE	BUDESONIDE	Aurobindo Pharma Limited	c70c734f-2431-4414-bb94-4adda4985e5d	2023-12-02	Warnings, Adverse reactions	Name fallback brand name: BUDESONIDE generic name: BUDESONIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7515	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7515	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7515	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7516	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7516	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7516	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7517	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7517	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
0781-7517	Budesonide	Budesonide	Sandoz Inc	ANDA	Current
68788-6796	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6796	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7020	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7020	Budesonide	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current