Application 019651

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ASACOL	MESALAMINE	TABLET, DELAYED RELEASE;ORAL	400MG	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
N019651-001	ASACOL	MESALAMINE	400MG	TABLET, DELAYED RELEASE / ORAL			1992-01-31

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`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 4 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mesalamine	MESALAMINE	Oceanside Pharmaceuticals	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	2023-10-31	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	cd8493f7-91fd-4c2d-b3d7-c1301825586b	2023-10-26	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	533bfaf5-0add-4b49-a4f2-ddea2b83f65d	2023-10-26	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0205	Asacol	mesalamine	State of Florida DOH Central Pharmacy	NDA	Current
53808-0823	ASACOL	mesalamine	State of Florida DOH Central Pharmacy	NDA	Current
55154-2305	Asacol	mesalamine	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64793	SUPPL	2020-10-02
64789	SUPPL	2020-10-02
49138	SUPPL	2017-07-28
49123	SUPPL	2017-07-28
11600	SUPPL	2015-05-29
17519	SUPPL	2015-05-28
11599	SUPPL	2013-10-22
1460	SUPPL	2013-10-21
11598	SUPPL	2010-05-28
1459	SUPPL	2010-05-28
17518	SUPPL	2009-11-12
33838	SUPPL	2009-10-06
1458	SUPPL	2007-04-20
20277	SUPPL	2003-06-18