Application 090410

Type: ANDA
Sponsor: MYLAN

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 43.

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
A090410-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2011-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090410-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090410-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090410-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090410-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090410-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090410-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090410-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090410-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090410-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090410-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090410-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090410-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090410-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090410-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090410-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090410-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090410-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090410-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090410-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090410-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090410-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090410-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090410-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090410-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090410-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090410-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090410-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090410-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090410-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090410-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090410-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090410-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090410-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090410-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090410-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090410-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090410-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090410-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090410-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090410-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090410-001	AB	1	`f41ea6bd6efb…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0378-7155	Budesonide	budesonide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7155	Budesonide	budesonide	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
68151-4374	Budesonide	budesonide	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22708	ORIG	2012-10-12
43239	ORIG	2012-09-26