Application 076751

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076751-001	MESALAMINE	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB		2004-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076751-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076751-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076751-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076751-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076751-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076751-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076751-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076751-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076751-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076751-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076751-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076751-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076751-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076751-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076751-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076751-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076751-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076751-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076751-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076751-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076751-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076751-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076751-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076751-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076751-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076751-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076751-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076751-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076751-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076751-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076751-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076751-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076751-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076751-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076751-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076751-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076751-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076751-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076751-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076751-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076751-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Bryant Ranch Prepack	1e561474-6169-410e-b83d-7e96d375831d	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 63629-8679
Mesalamine	MESALAMINE	Bryant Ranch Prepack	9756d07b-2939-460f-94d3-e338c28cb993	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 63629-8678
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 45802-929
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	d50f2c37-5675-49f3-bdd4-3b16d333ed40	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 45802-923
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	a4ddf68d-1502-4242-89aa-c96436bdcbf6	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 45802-098

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-098	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-098	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-098	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-098	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-098	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-098	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-098	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-923	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-923	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-929	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-929	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-929	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-929	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-929	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
45802-929	Mesalamine	Mesalamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-929	Mesalamine	Mesalamine	Perrigo New York Inc	ANDA	Current
63629-8678	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current
63629-8678	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current
63629-8678	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current
63629-8679	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current
63629-8679	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current
63629-8679	Mesalamine	Mesalamine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22584	ORIG	2007-04-02
31158	ORIG	2004-09-17