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 1.

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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`8072bd15b7f6…`

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 1 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Rising Pharma Holdings, Inc.	3235e2a4-8e12-2d58-e063-6294a90a4936	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Cipla USA Inc.	c52c5382-1400-44b9-95be-a30e1cf706da	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	REMEDYREPACK INC.	5e39c491-2793-410e-b77f-8b3cbe9b6231	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	American Health Packaging	c7df2a10-4166-423e-bb60-5f3a8234f26c	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Cardinal Health 107, LLC	3e8a6cf4-4bda-4e22-8653-12635adfb316	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Sun Pharmaceutical Industries, Inc.	a39fbcfc-3ffd-44bd-b882-01f8e1844213	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide Inhalation	BUDESONIDE	Preferred Pharmaceuticals Inc.	1d139a25-9c17-4b3e-8ffd-b2d562cc00ee	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	American Health Packaging	4a8e79df-3946-4e9a-b214-e9fdd824b565	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Rugby Laboratories	04eb9e98-1323-353f-3fd7-2d317dfac526	2026-02-27	Warnings	Name fallback brand name: Budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Bryant Ranch Prepack	33def4dc-b469-f987-e063-6294a90ace0b	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
Budesonide Inhalation	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	e8ef9489-83a2-4817-b21c-ea3fecd8c8dd	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Tarpeyo	BUDESONIDE	Calliditas Therapeutics AB	938cada4-d6bf-4252-836f-dd40f9eadb4d	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Walgreens	9d519bf3-8d9b-5208-13c5-308edc24aca7	2026-01-21	Warnings	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	CVS Pharmacy	b2650d29-c011-48f1-a7f4-040011d4563d	2026-01-21	Warnings	Name fallback brand name: Budesonide generic name: BUDESONIDE
budesonide	BUDESONIDE	Golden State Medical Supply, Inc.	263303c2-8e4f-7b6c-e063-6394a90aef9e	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Rugby Laboratories	b83af99e-1619-48ed-a033-e5207033f77e	2025-12-09	Warnings	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Apotex Corp.	f1aac35a-bc72-dd68-8179-8661354589cb	2025-09-22	Warnings	Name fallback brand name: Budesonide generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	Rubicon Holdings Inc.	ae1105cd-69fc-4c15-937f-c535304341c2	2025-09-04	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	10336e42-0e9d-45c4-80bc-5149d5ec9e1c	2025-06-19	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