Application 206134

Type: ANDA
Sponsor: ZYDUS 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
A206134-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2017-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206134-001	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	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`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	A206134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206134-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206134-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206134-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206134-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206134-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206134-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206134-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206134-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206134-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206134-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide	BUDESONIDE	REMEDYREPACK INC.	5e39c491-2793-410e-b77f-8b3cbe9b6231	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
Budesonide	BUDESONIDE	American Health Packaging	4a8e79df-3946-4e9a-b214-e9fdd824b565	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134 ndc (product): 60687-596
budesonide	BUDESONIDE	Major Pharmaceuticals	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
budesonide	BUDESONIDE	Northstar Rx LLC.	a37866df-df07-4f71-8591-98c2804c4794	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134 ndc (product): 16714-829
budesonide	BUDESONIDE	Zydus Pharmaceuticals USA Inc.	29863154-5f98-410e-9bf3-0f08b551edef	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134 ndc (product): 68382-720
budesonide	BUDESONIDE	Zydus Lifesciences Limited	d645a346-c99b-4de7-9bca-69e73266d6b4	2025-02-12		Exact identifier application applno (ANDA): 206134 application number: ANDA206134 ndc (product): 70771-1075

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
16714-829	budesonide	budesonide	Northstar Rx LLC.	ANDA	Current
60687-596	Budesonide	Budesonide	American Health Packaging	ANDA	Current
60687-596	Budesonide	Budesonide	American Health Packaging	ANDA	Current
68382-720	budesonide	budesonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-720	budesonide	budesonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-720	budesonide	budesonide	Zydus Pharmaceuticals (US	ANDA	Current
68382-720	budesonide	budesonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-720	budesonide	budesonide	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1075	budesonide	budesonide	Cadila Healthcare Limited	ANDA	Current
70771-1075	budesonide	budesonide	Cadila Healthcare Limited	ANDA	Current
70771-1075	budesonide	budesonide	Cadila Healthcare Limited	ANDA	Current
70771-1075	budesonide	budesonide	Cadila Healthcare Limited	ANDA	Current
70771-1075	budesonide	budesonide	Zydus Lifesciences Limited	ANDA	Current