Application 210897

Type: ANDA
Sponsor: LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	SUSPENSION;INHALATION	0.5MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210897-001	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2018-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210897-001	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 2 · 42 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	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A210897-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210897-001	AN	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide inhalation	BUDESONIDE INHALATION	Preferred Pharmaceuticals, Inc.	dd74e446-7c1b-4f02-9c73-ba716572ee77	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
Budesonide Inhalation	BUDESONIDE INHALATION	American Health Packaging	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897 ndc (product): 60687-524
budesonide inhalation	BUDESONIDE INHALATION	A-S Medication Solutions	87048fa9-3391-4f30-801d-b96ca0132f56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
budesonide inhalation	BUDESONIDE INHALATION	Lupin Pharmaceuticals, Inc.	944cbb7c-b41d-4a6d-8a93-2e646365c982	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897 ndc (product): 68180-984

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-524	Budesonide Inhalation	Budesonide Inhalation	American Health Packaging	ANDA	Current
60687-524	Budesonide Inhalation	Budesonide Inhalation	American Health Packaging	ANDA	Current
60687-524	Budesonide Inhalation	Budesonide Inhalation	American Health Packaging	ANDA	Current
65302-042	Budesonide Inhalation	Budesonide Inhalation Suspension	The Ritedose Corporation	ANDA	Current
68180-984	budesonide inhalation	budesonide inhalation	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-984	budesonide inhalation	budesonide inhalation	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-984	budesonide inhalation	budesonide inhalation	Lupin Pharmaceuticals, Inc.	ANDA	Current
76204-018	Budesonide Inhalation Suspension	Budesonide Inhalation Suspension	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-018	Budesonide Inhalation Suspension	Budesonide Inhalation Suspension	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-018	Budesonide Inhalation Suspension	Budesonide Inhalation Suspension	Ritedose Pharmaceuticals, LLC	ANDA	Current