Application 022301

Type: NDA
Sponsor: VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APRISO	MESALAMINE	CAPSULE, EXTENDED RELEASE;ORAL	375MG	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
N022301-001	APRISO	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022301-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022301-001	8865688	2030-05-01	U-1310		2014-10-22

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	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`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	N022301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022301-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
APRISO	MESALAMINE	Salix Pharmaceuticals, Inc.	7951139c-b271-45a4-b523-34b23800917b	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301 ndc (product): 65649-103
mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	8d27a608-3ba1-4799-be38-c00fb08ce3ce	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301 ndc (product): 0093-9224
mesalamine	MESALAMINE	Oceanside Pharmaceuticals	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301 ndc (product): 68682-113

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-9224	mesalamine	mesalamine	Teva Pharmaceuticals USA, Inc.-	NDA AUTHORIZED GENERIC	Current
0093-9224	mesalamine	mesalamine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-9224	mesalamine	mesalamine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-9224	mesalamine	mesalamine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
43353-884	APRISO	mesalamine	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
63629-8827	mesalamine	mesalamine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8827	mesalamine	mesalamine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, In	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
65649-103	APRISO	mesalamine	Salix Pharmaceuticals, Inc.	NDA	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-113	mesalamine	mesalamine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70748-214	mesalamine	mesalamine	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70748-214	mesalamine	mesalamine	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70748-214	mesalamine	mesalamine	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70748-214	mesalamine	mesalamine	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75930	SUPPL	2023-10-25
72647	SUPPL	2022-11-17
72625	SUPPL	2022-11-17
69191	SUPPL	2021-11-02
69186	SUPPL	2021-11-02
64859	SUPPL	2020-10-07
64802	SUPPL	2020-10-02
57978	SUPPL	2019-03-13
49182	SUPPL	2017-08-02
49144	SUPPL	2017-07-31
44730	ORIG	2009-12-30
21986	ORIG	2009-12-30
17213	ORIG	2008-11-07
7202	ORIG	2008-11-07