Application 021324

Type: NDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENTOCORT EC	BUDESONIDE	CAPSULE;ORAL	3MG	Yes	Yes

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
N021324-001	ENTOCORT EC	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021324-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`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	N021324-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021324-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021324-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021324-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021324-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021324-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021324-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021324-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021324-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021324-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021324-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021324-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021324-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021324-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021324-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021324-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021324-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021324-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021324-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021324-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021324-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021324-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021324-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021324-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021324-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021324-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021324-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021324-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021324-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021324-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021324-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021324-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021324-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021324-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021324-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021324-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021324-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021324-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021324-001	M-178	2019-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021324-001	NPP	2019-04-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021324-001	M-178	2019-04-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021324-001	NPP	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	M-178	2019-04-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021324-001	NPP	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	M-178	2019-04-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021324-001	NPP	2019-04-29	`ea99ee380514…`

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	Bryant Ranch Prepack	33def4dc-b469-f987-e063-6294a90ace0b	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324
budesonide	BUDESONIDE	Golden State Medical Supply, Inc.	263303c2-8e4f-7b6c-e063-6394a90aef9e	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324
budesonide	BUDESONIDE	Padagis US LLC	3a18d5a7-04c5-4137-8155-70a8adc0a48b	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324 ndc (product): 0574-9855

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
0574-9850	Entocort EC	Budesonide	Paddock Laboratories, LLC	NDA	Current
0574-9850	Entocort EC	Budesonide	Paddock Laboratories, LLC	NDA	Current
0574-9850	Entocort EC	Budesonide	Padagis US LLC	NDA	Current
0574-9850	Entocort EC	Budesonide	Paddock Laboratories, LLC	NDA	Current
0574-9855	budesonide	budesonide	Padagis US LLC	NDA	Current
0574-9855	budesonide	budesonide	Padagis US LLC	NDA	Current
0574-9855	budesonide	budesonide	Paddock Laboratories, LLC.	NDA	Current
0574-9855	budesonide	budesonide	Paddock Laboratories, LLC	NDA	Current
0574-9855	budesonide	budesonide	Paddock Laboratories, LLC	NDA	Current
65483-702	ENTOCORT	Budesonide	Prometheus Laboratories Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78718	SUPPL	2024-06-07
78660	SUPPL	2024-06-06
63955	SUPPL	2020-07-17
63920	SUPPL	2020-07-15
57301	SUPPL	2019-01-22
57290	SUPPL	2019-01-22
62322	SUPPL	2019-01-18
50108	SUPPL	2017-10-19
50098	SUPPL	2017-10-19
36666	SUPPL	2016-05-03
27492	SUPPL	2016-05-03
15197	SUPPL	2016-05-03
5048	SUPPL	2016-05-03
15196	SUPPL	2011-12-23
27491	SUPPL	2011-12-22
15195	SUPPL	2009-06-24
5047	SUPPL	2009-06-24
62321	SUPPL	2009-06-22
36665	SUPPL	2005-05-03
5046	SUPPL	2005-05-03
27490	SUPPL	2004-06-03
5044	SUPPL	2004-06-03
23071	ORIG	2003-05-07
5045	SUPPL	2003-03-26
36664	ORIG	2001-10-02
27489	ORIG	2001-10-02
21601	ORIG	2001-10-02
52053	ORIG	1900-01-01
52051	SUPPL	1900-01-01
52050	ORIG	1900-01-01