Application 078404

Type: ANDA
Sponsor: IMPAX LABS INC

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078404-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN		2012-07-31
A078404-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2012-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078404-001	AN
A078404-002	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 · 82 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	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078404-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078404-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2012-07-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078404-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078404-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078404-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078404-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078404-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078404-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078404-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078404-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078404-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078404-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078404-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078404-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078404-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078404-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078404-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078404-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078404-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078404-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078404-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078404-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078404-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078404-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078404-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078404-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078404-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078404-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078404-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078404-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078404-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078404-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078404-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078404-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078404-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078404-002	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078404-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078404-002	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078404-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078404-002	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078404-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078404-002	AN	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide Inhalation	BUDESONIDE	Preferred Pharmaceuticals Inc.	1d139a25-9c17-4b3e-8ffd-b2d562cc00ee	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078404 application number: ANDA078404
Budesonide Inhalation	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	e8ef9489-83a2-4817-b21c-ea3fecd8c8dd	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078404 application number: ANDA078404 ndc (product): 0115-1689 ndc (product): 0115-1687

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1687	Budesonide Inhalation	Budesonide	Impax Generics	ANDA	Current
0115-1687	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1687	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1687	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1687	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1689	Budesonide Inhalation	Budesonide	Impax Generics	ANDA	Current
0115-1689	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1689	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1689	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1689	Budesonide Inhalation	Budesonide	Amneal Pharmaceuticals of New York LLC	ANDA	Current
68788-3768	Budesonide Inhalation	Budesonide	Preferred Pharmaceuticals Inc.	ANDA	Current