Application 204412

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DELZICOL	MESALAMINE	CAPSULE, DELAYED RELEASE;ORAL	400MG	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
N204412-001	DELZICOL	MESALAMINE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01

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	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204412-001	DELZICOL	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-02-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204412-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204412-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204412-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204412-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204412-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204412-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204412-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204412-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204412-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204412-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204412-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204412-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204412-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204412-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204412-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204412-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204412-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204412-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204412-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204412-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204412-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204412-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204412-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204412-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204412-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204412-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204412-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204412-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204412-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204412-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204412-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204412-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204412-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204412-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204412-001	6649180	2020-04-13	Drug product	2013-07-12	`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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rowasa	MESALAMINE	Viatris Specialty LLC	e505ab99-1943-4216-a178-4d5dbe64e3b2	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Major Pharmaceuticals	14ac4435-903b-41f5-a3c4-8c73de3e4cef	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	ad8c7930-92e2-4372-a874-da22b9ae333e	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Sandoz Inc	47b5d1ee-b439-4ccb-9b01-c0875ccd748a	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Nuvaila Limited	875d573f-99a1-426a-8321-4d511690d503	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	ANI Pharmaceuticals, Inc.	485ed763-976e-4410-a401-7ff762a931b3	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
MESALAMINE	MESALAMINE	KLM Laboratories Private Limited	54cfed92-5e28-4a4d-a70f-2a60b5b54c12	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Lialda	MESALAMINE	Takeda Pharmaceuticals America, Inc.	3098a080-be86-4265-9818-7fc4beab77b7	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Golden State Medical Supply, Inc.	4c4ffb68-3ca4-35cd-e063-6294a90ab929	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Actavis Pharma, Inc.	73317da3-cba0-4106-9e88-79b0e2f642af	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	AvKARE	22f3ee49-ac57-84f5-e063-6394a90aae91	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Chartwell RX, LLC	9703f92d-1d15-4376-8b2b-51502c266012	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
MESALAMINE	MESALAMINE	Camber Pharmaceuticals, Inc.	ef471372-8d9f-4d95-9371-44522c69058f	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Rising Pharma Holdings, Inc.	c26ae6cb-041b-4cfc-90ca-c4e1cb23458c	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Ingenus Pharmaceuticals, LLC	58503afe-b8d4-4710-a194-e3acd64ecf1f	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Upsher-Smith Laboratories, LLC	1e6978d0-01db-477d-a90f-27561777480f	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Encube Ethicals, Inc.	d6b68275-b2a4-4965-9862-cf14acf8c599	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	6fd0a906-e1b5-4238-a79b-a195510ddc84	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	American Health Packaging	e638681d-8fca-4bf8-a1fb-8e52357a64da	2025-05-21	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Actavis Pharma, Inc.	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE

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
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
0023-5853	Delzicol	mesalamine	Allergan, Inc.	NDA	Current
50090-3002	Delzicol	mesalamine	A-S Medication Solutions	NDA	Current
50090-3002	Delzicol	mesalamine	A-S Medication Solutions	NDA	Current
50090-3002	Delzicol	mesalamine	A-S Medication Solutions	NDA	Current
59762-0117	MESALAMINE	MESALAMINE	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0117	MESALAMINE	MESALAMINE	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0117	MESALAMINE	MESALAMINE	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0117	MESALAMINE	MESALAMINE	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0117	MESALAMINE	MESALAMINE	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
68151-5652	Delzicol	mesalamine	Carilion Materials Management	NDA	Current
70518-3239	MESALAMINE	MESALAMINE	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75945	SUPPL	2023-10-25
75931	SUPPL	2023-10-25
72648	SUPPL	2022-11-17
72624	SUPPL	2022-11-17
69196	SUPPL	2021-11-02
69190	SUPPL	2021-11-02
65828	SUPPL	2021-01-06
64860	SUPPL	2020-10-07
64803	SUPPL	2020-10-02
64108	SUPPL	2020-07-28
49140	SUPPL	2017-07-28
49124	SUPPL	2017-07-28
40389	SUPPL	2015-09-22
10341	SUPPL	2015-09-10
40388	SUPPL	2014-10-29
10340	SUPPL	2014-10-28
32557	SUPPL	2014-04-29
19557	SUPPL	2014-04-29
43463	ORIG	2013-06-10
32556	ORIG	2013-02-05
19556	ORIG	2013-02-05
51349	ORIG	1900-01-01
51348	ORIG	1900-01-01
51347	ORIG	1900-01-01
51346	SUPPL	1900-01-01
51345	SUPPL	1900-01-01
51344	SUPPL	1900-01-01