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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	A-S Medication Solutions	32e30f11-e19b-4e23-a893-92d95e48edef	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	10ea5d87-6ed0-4fa5-a37b-2043c8560bc0	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2b	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
BUDESONIDE	BUDESONIDE	Padagis Israel Pharmaceuticals Ltd	ad4a68e7-9200-4f05-8058-714d5d8900f8	2023-04-17	Warnings, Adverse reactions	Name fallback brand name: BUDESONIDE generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	79fc8cf4-bb33-4892-9dd2-641d7e943a01	2023-02-04	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73	2021-10-01	Warnings, Adverse reactions	Name fallback brand name: budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	4f126a29-38f7-4c4c-8978-37e72b289902	2021-01-12	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	2414058b-5d39-42f2-915f-03a5e1101ab5	2021-01-12	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Exelan Pharmaceuticals, Inc.	d9656442-4587-4867-9a8c-5f5b0402936e	2020-12-11	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Uceris	BUDESONIDE	Salix Pharmaceuticals, Inc.	230e4596-2a9b-4d55-b0a0-0cabbcff5289	2020-04-23	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	d90ffda1-12c7-4726-90e9-64bb103e84b5	2019-10-31	Warnings, Adverse reactions	Name fallback brand name: Budesonide generic name: BUDESONIDE
PULMICORT RESPULES	BUDESONIDE	AstraZeneca Pharmaceuticals LP	33cd9834-76df-4f26-3fa2-aab6b9eee8f2	2019-10-11	Warnings, Adverse reactions	Name fallback 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