Application 203574

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MESALAMINE	MESALAMINE	TABLET, DELAYED RELEASE;ORAL	1.2GM	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
A203574-001	MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL			2018-11-20

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203574-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2018-11-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203574-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203574-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203574-001	AB	1	`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 3 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	d50f2c37-5675-49f3-bdd4-3b16d333ed40	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	a4ddf68d-1502-4242-89aa-c96436bdcbf6	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Ascend Laboratories, LLC	43f69db3-81ac-4da4-a61f-fbba6299d9c2	2024-07-03	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Teva Pharmaceuticals, Inc.	e3b84397-a5a5-40cf-8145-0584103d465f	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	06792d20-d7e9-4b66-a4cb-cd0cf1a2db25	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Rising Pharma Holdings, Inc.	de981df1-747a-480d-a866-e72332a1544d	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
MESALAMINE	MESALAMINE	Bryant Ranch Prepack	063ca661-1b5c-4941-a5b9-5dd0fa46b3d0	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: MESALAMINE generic name: MESALAMINE
Mesalamine	MESALAMINE	Amneal Pharmaceuticals LLC	00f77203-3615-47e8-ae25-6e1cf8a2a00a	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	c9b1ef9d-1d06-48e7-87d2-7985b99124a6	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
mesalamine	MESALAMINE	Golden State Medical Supply, Inc.	170657d1-1f32-f036-e063-6294a90a4ed4	2024-04-26	Warnings, Adverse reactions	Name fallback brand name: mesalamine generic name: MESALAMINE
MESALAMINE	MESALAMINE	Lannett Company Inc.	29dbe417-15a9-4c4d-846b-81cabda7ac70	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: MESALAMINE generic name: MESALAMINE
Mesalamine	MESALAMINE	Camber Pharmaceuticals, Inc.	efa9d039-ae1f-4cd6-98f2-e87a901dfaeb	2024-02-26	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Camber Pharmaceuticals, Inc.	04ce2182-2e8c-4598-a269-550cfaddde6c	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	ANI Pharmaceuticals, Inc.	3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Aurobindo Pharma Limited	d6c0fc76-644e-4301-9672-f432061e3d37	2024-01-20	Warnings, Adverse reactions	Name fallback brand name: Mesalamine generic name: MESALAMINE
MESALAMINE	MESALAMINE	Alembic Pharmaceuticals Inc.	87d3d62d-2dc3-4e6f-be33-cabbca12e8f7	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: MESALAMINE generic name: MESALAMINE
mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	8d27a608-3ba1-4799-be38-c00fb08ce3ce	2023-12-19	Warnings, Adverse reactions	Name fallback brand name: mesalamine 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 brand name: Mesalamine generic name: MESALAMINE
Mesalamine	MESALAMINE	Mylan Pharmaceuticals Inc.	c8b93ea3-0367-4605-b87f-06c3812ff3b7	2023-11-30	Warnings, Adverse reactions	Name fallback brand name: Mesalamine 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
0378-7401	Mesalamine	mesalamine Film Coated	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7401	Mesalamine	mesalamine Film Coated	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7401	Mesalamine	mesalamine Film Coated	Mylan Pharmaceuticals Inc.	ANDA	Current