Application 203286

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MESALAMINE	MESALAMINE	TABLET, DELAYED RELEASE;ORAL	800MG	No	No

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
A203286-001	MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203286-001	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 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	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203286-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203286-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203286-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203286-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203286-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203286-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203286-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203286-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203286-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203286-001	AB	1	`d06236e962d9…`
2022-04-08 23:34 UTC	2022-04	A203286-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203286-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203286-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203286-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203286-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203286-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203286-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203286-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203286-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203286-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203286-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203286-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203286-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mesalamine	MESALAMINE	Major Pharmaceuticals	14ac4435-903b-41f5-a3c4-8c73de3e4cef	2026-07-27	Warnings, Adverse reactions	Exact identifier ndc (product): 0904-6832
mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	ad8c7930-92e2-4372-a874-da22b9ae333e	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203286 application number: ANDA203286 ndc (product): 68382-435
mesalamine	MESALAMINE	Zydus Lifesciences Limited	52d96501-47f3-45d8-a181-98763b9f8965	2024-11-30		Exact identifier application applno (ANDA): 203286 application number: ANDA203286 ndc (product): 70771-1110
Mesalamine	MESALAMINE	American Health Packaging	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203286 application number: ANDA203286 ndc (product): 60687-408

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6832	mesalamine	mesalamine	Major Pharmaceuticals	ANDA	Current
60687-408	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
60687-408	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
60687-408	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
60687-408	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-435	mesalamine	mesalamine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1543	ZALDYON	mesalamine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1110	mesalamine	mesalamine	Cadila Healthcare Limited	ANDA	Current
70771-1110	mesalamine	mesalamine	Cadila Healthcare Limited	ANDA	Current
70771-1110	mesalamine	mesalamine	Zydus Lifesciences Limited	ANDA	Current
70771-1110	mesalamine	mesalamine	Cadila Healthcare Limited	ANDA	Current
70771-1353	ZALDYON	mesalamine	Cadila Healthcare Limited	ANDA	Current
70771-1353	ZALDYON	mesalamine	Zydus Lifesciences Limited	ANDA	Current
70771-1353	ZALDYON	mesalamine	Cadila Healthcare Limited	ANDA	Current
70771-1353	ZALDYON	mesalamine	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65827	ORIG	2021-01-06
49102	ORIG	2017-07-27