Application 022000

Type: NDA
Sponsor: SHIRE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIALDA	MESALAMINE	TABLET, DELAYED RELEASE;ORAL	1.2GM	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
N022000-001	LIALDA	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022000-001	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	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`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	N022000-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022000-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022000-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022000-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022000-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022000-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022000-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022000-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022000-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022000-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022000-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022000-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022000-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022000-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022000-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022000-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022000-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022000-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022000-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022000-001	6773720	2020-06-08	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022000-001	6773720	2020-06-08	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	6773720	2020-06-08	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	6773720	2020-06-08	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	6773720	2020-06-08	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	6773720	2020-06-08	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	NPP	2023-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	NPP	2023-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	NPP	2023-06-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022000-001	NPP	2023-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	NPP	2023-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	NPP	2023-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	NPP	2023-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	NPP	2023-06-26	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	N022000-001	NPP	2023-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	NPP	2023-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	NPP	2023-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	NPP	2023-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	NPP	2023-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	NPP	2023-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	NPP	2023-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	NPP	2023-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	NPP	2023-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	NPP	2023-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	NPP	2023-06-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lialda	MESALAMINE	Takeda Pharmaceuticals America, Inc.	3098a080-be86-4265-9818-7fc4beab77b7	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022000 application number: NDA022000 ndc (product): 54092-476
Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022000 application number: NDA022000 ndc (product): 54092-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0142	Lialda	mesalamine	KAISER FOUNDATION HOSPITA	NDA	Current
54092-100	Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-100	Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-100	Mesalamine	MESALAMINE	Shire US Manufacturing Inc.	NDA AUTHORIZED GENERIC	Current
54092-100	Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-100	Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-100	Mesalamine	MESALAMINE	Shire US Manufacturing Inc.	NDA AUTHORIZED GENERIC	Current
54092-476	Lialda	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-476	Lialda	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-476	Lialda	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-476	Lialda	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75944	SUPPL	2023-10-25
75929	SUPPL	2023-10-25
72646	SUPPL	2022-11-17
72626	SUPPL	2022-11-17
69193	SUPPL	2021-11-02
69184	SUPPL	2021-11-02
67653	SUPPL	2021-06-02
67593	SUPPL	2021-05-26
65653	SUPPL	2020-12-21
65612	SUPPL	2020-12-17
64866	SUPPL	2020-10-07
64817	SUPPL	2020-10-05
63785	SUPPL	2020-07-02
63752	SUPPL	2020-06-30
59385	SUPPL	2019-07-19
59376	SUPPL	2019-07-19
54340	SUPPL	2018-05-25
54329	SUPPL	2018-05-24
49538	SUPPL	2017-08-25
49523	SUPPL	2017-08-24
49143	SUPPL	2017-07-31
49127	SUPPL	2017-07-28
42382	SUPPL	2015-03-09
29040	SUPPL	2014-10-21
16739	SUPPL	2014-10-21
29039	SUPPL	2013-12-17
16738	SUPPL	2013-12-17
16736	SUPPL	2013-09-24
6654	SUPPL	2013-08-29
38060	SUPPL	2013-08-12
29038	SUPPL	2013-08-12
16737	SUPPL	2013-08-12
6655	SUPPL	2013-08-12
38059	SUPPL	2011-07-18
6653	SUPPL	2011-07-18
29037	SUPPL	2010-09-27
16735	SUPPL	2010-09-23
38058	SUPPL	2009-12-10
42381	ORIG	2007-08-31
29036	ORIG	2007-01-25
16734	ORIG	2007-01-18