Application 019618

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROWASA	MESALAMINE	ENEMA;RECTAL	4GM/60ML	Yes	Yes
002	SFROWASA	MESALAMINE	ENEMA;RECTAL	4GM/60ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019618-001	ROWASA	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24
N019618-002	SFROWASA	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019618-001	AB
N019618-002	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
N019618-002	7645801	2027-07-24		Drug substance, Drug product

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 3 · 82 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	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019618-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019618-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019618-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019618-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019618-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019618-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019618-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019618-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019618-002	AB	1	`782e0a99824c…`

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	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`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 · 2 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	Exact identifier application applno (NDA): 019618 application number: NDA019618 ndc (product): 0037-0066
Mesalamine	MESALAMINE	ANI Pharmaceuticals, Inc.	3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019618 application number: NDA019618 ndc (product): 62559-420

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals Inc.	NDA	Current
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0022	sfRowasa	mesalamine	Meda Pharmaceuticals Inc.	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals Inc.	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals Inc.	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals Inc.	NDA	Current
0037-0066	Rowasa	mesalamine	Meda Pharmaceuticals	NDA	Current
62559-420	Mesalamine	Mesalamine	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-420	Mesalamine	Mesalamine	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-420	Mesalamine	Mesalamine	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-420	Mesalamine	Mesalamine	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79267	SUPPL	2024-08-02
79257	SUPPL	2024-07-31
75925	SUPPL	2023-10-25
72640	SUPPL	2022-11-17
72632	SUPPL	2022-11-17
69209	SUPPL	2021-11-02
69202	SUPPL	2021-11-02
67949	SUPPL	2021-06-29
67923	SUPPL	2021-06-28
64867	SUPPL	2020-10-07
64792	SUPPL	2020-10-02
49137	SUPPL	2017-07-28
49122	SUPPL	2017-07-28
11565	SUPPL	2015-05-26
17488	SUPPL	2008-06-24
1421	SUPPL	2006-01-06