Application 020049

Type: NDA
Sponsor: SHIRE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENTASA	MESALAMINE	CAPSULE, EXTENDED RELEASE;ORAL	250MG	Yes	No
002	PENTASA	MESALAMINE	CAPSULE, EXTENDED RELEASE;ORAL	500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020049-001	PENTASA	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10
N020049-002	PENTASA	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020049-001	AB
N020049-002	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 3 · 90 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
2026-11-14 07:37:17	2026-10	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N020049-001	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N020049-002	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N020049-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020049-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020049-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020049-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020049-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020049-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020049-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020049-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020049-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020049-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020049-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020049-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020049-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020049-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020049-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020049-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020049-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020049-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020049-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020049-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020049-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020049-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020049-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020049-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020049-002	AB	1	`a50c72e98297…`

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 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	ANI Pharmaceuticals, Inc.	3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac	2024-02-14	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Aurobindo Pharma Limited	d6c0fc76-644e-4301-9672-f432061e3d37	2024-01-20	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
MESALAMINE	MESALAMINE	Alembic Pharmaceuticals Inc.	87d3d62d-2dc3-4e6f-be33-cabbca12e8f7	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	8d27a608-3ba1-4799-be38-c00fb08ce3ce	2023-12-19	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine Rectal	MESALAMINE	Amring Pharmaceuticals Inc.	87de237c-febb-42ca-b2a4-b444396f8640	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Sun Pharmaceutical Industries, Inc.	fd8b02de-7dfa-444d-a1f8-1436b578e0cb	2023-12-01	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Mylan Pharmaceuticals Inc.	c8b93ea3-0367-4605-b87f-06c3812ff3b7	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
MESALAMINE	MESALAMINE	Alembic Pharmaceuticals Limited	4ef59b85-e5a5-479f-a1fe-e1cee4d87670	2022-11-07	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-189	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Shire US Manufacturing Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-191	Pentasa	mesalamine	Takeda Pharmaceuticals America, Inc.	NDA	Current
68151-4769	Pentasa	mesalamine	Carilion Materials Management	NDA	Current
69189-0189	Pentasa	mesalamine	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79272	SUPPL	2024-08-02
79259	SUPPL	2024-07-31
75938	SUPPL	2023-10-25
75926	SUPPL	2023-10-25
72642	SUPPL	2022-11-17
72630	SUPPL	2022-11-17
69207	SUPPL	2021-11-02
69200	SUPPL	2021-11-02
67656	SUPPL	2021-06-02
67598	SUPPL	2021-05-26
65770	SUPPL	2020-12-28
65113	SUPPL	2020-11-02
64863	SUPPL	2020-10-07
64796	SUPPL	2020-10-02
59369	SUPPL	2019-07-18
59364	SUPPL	2019-07-17
54380	SUPPL	2018-05-31
54318	SUPPL	2018-05-24
49539	SUPPL	2017-08-25
49533	SUPPL	2017-08-24
49142	SUPPL	2017-07-31
49126	SUPPL	2017-07-28
41135	SUPPL	2015-11-18
21080	SUPPL	2015-08-10
34209	SUPPL	2015-08-07
21079	SUPPL	2013-12-17
12163	SUPPL	2013-12-17
34208	SUPPL	2013-07-30
21078	SUPPL	2013-07-26
41134	SUPPL	2007-11-19
21077	SUPPL	2007-07-05
1951	SUPPL	2006-07-03
1950	SUPPL	2004-07-14
41133	SUPPL	1999-09-10
21076	SUPPL	1999-09-10
12162	SUPPL	1999-09-10
41132	ORIG	1998-02-18