Application 206200

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	CAPSULE;ORAL	3MG	No	No

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

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
A206200-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2017-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206200-001	AB

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 · 41 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	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206200-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206200-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-07-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206200-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206200-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206200-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206200-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206200-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206200-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206200-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206200-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206200-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206200-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206200-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206200-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206200-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206200-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206200-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206200-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206200-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206200-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206200-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206200-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206200-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206200-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206200-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206200-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206200-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206200-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206200-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206200-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206200-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206200-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206200-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206200-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206200-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206200-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206200-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206200-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206200-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206200-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206200-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206200-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	10336e42-0e9d-45c4-80bc-5149d5ec9e1c	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206200 application number: ANDA206200
Budesonide	BUDESONIDE	Bryant Ranch Prepack	4943ef5b-f48b-49d6-b419-467f71ef64e0	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206200 application number: ANDA206200 ndc (product): 63629-8294
Budesonide	BUDESONIDE	Amneal Pharmaceuticals LLC	b15102d5-7884-44ed-8340-046d7b516fa8	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206200 application number: ANDA206200 ndc (product): 65162-778

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7166	Budesonide	Budesonide	Major Pharmaceuticals	ANDA	Current
0904-7166	Budesonide	Budesonide	Major Pharmaceuticals	ANDA	Current
63629-8294	Budesonide	Budesonide	Bryant Ranch Prepack	ANDA	Current
63629-8294	Budesonide	Budesonide	Bryant Ranch Prepack	ANDA	Current
65162-778	Budesonide	Budesonide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-778	Budesonide	Budesonide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-778	Budesonide	Budesonide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-778	Budesonide	Budesonide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-778	Budesonide	Budesonide	Amneal Pharmaceuticals LLC	ANDA	Current