Application 019919

Type: NDA
Sponsor: MEDA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROWASA	MESALAMINE	SUPPOSITORY;RECTAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N019919-001	ROWASA	MESALAMINE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL		RLD	1990-12-18

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019919-001	ROWASA	500MG	SUPPOSITORY / RECTAL	RLD	1990-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019919-001	ROWASA	500MG	SUPPOSITORY / RECTAL	RLD	1990-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019919-001	ROWASA	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1990-12-18	`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 2 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Actavis Pharma, Inc.	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Pentasa	MESALAMINE	Takeda Pharmaceuticals America, Inc.	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	2025-01-15	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Northstar Rx LLC.	7ac78fa0-60a8-48dd-abc4-a487f98039a2	2025-01-10	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	AvPAK	f2657911-6f06-71fb-e053-2a95a90ae6f7	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Zydus Lifesciences Limited	aa63b4bb-2de7-40aa-b26b-1b00b0183eac	2025-01-09		Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	f458d574-7b5b-44f1-86be-8b18880dc67f	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Zydus Lifesciences Limited	29c0dd58-d2cf-40fa-bc32-0eab61937331	2024-11-30		Name fallback generic name: MESALAMINE
mesalamine	MESALAMINE	Zydus Lifesciences Limited	52d96501-47f3-45d8-a181-98763b9f8965	2024-11-30		Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Zydus Lifesciences Limited	04073681-a834-4f45-91c5-224b608b30e6	2024-11-30		Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	American Health Packaging	77140634-9f32-40ca-8c83-9fcc3e373c16	2024-11-22	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	NorthStar RxLLC	8233f158-9da5-4fd2-b2c3-9db89448371f	2024-11-21	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	American Health Packaging	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	2024-11-21	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	1e561474-6169-410e-b83d-7e96d375831d	2024-11-07	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	9756d07b-2939-460f-94d3-e338c28cb993	2024-11-07	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	b48df65a-a717-479e-9122-8b0f1406c841	2024-11-01	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Canasa	MESALAMINE	Allergan, Inc.	89d91601-152b-4398-bebe-af1c023e9935	2024-09-08	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Sun Pharmaceutical Industries Inc.	c2f84490-70b8-4998-907d-a77e9f791de1	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Bryant Ranch Prepack	baa76dde-3c5b-4ff4-ba0c-f19660a796c1	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	2024-08-01	Warnings, Adverse reactions	Name fallback generic name: MESALAMINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41095	SUPPL	1997-08-08