Application 207873

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MESALAMINE	MESALAMINE	CAPSULE, DELAYED RELEASE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207873-001	MESALAMINE	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE / ORAL		RS	2019-05-09

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A207873-001	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207873-001	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207873-001	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-05-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207873-001	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE / ORAL		RS	2019-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207873-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207873-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207873-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207873-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207873-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207873-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207873-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207873-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207873-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207873-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207873-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207873-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207873-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207873-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207873-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207873-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207873-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207873-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207873-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207873-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207873-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207873-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207873-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207873-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207873-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207873-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207873-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207873-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207873-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207873-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207873-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207873-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207873-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207873-001	AB	1	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	6fd0a906-e1b5-4238-a79b-a195510ddc84	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207873 application number: ANDA207873 ndc (product): 0093-5907

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5907	Mesalamine	Mesalamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-563	Mesalamine	Mesalamine	AvKARE, Inc	ANDA	Current
42291-563	Mesalamine	Mesalamine	AvKARE	ANDA	Current
42291-563	Mesalamine	Mesalamine	AvKARE	ANDA	Current
60687-556	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
60687-556	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current
60687-556	Mesalamine	Mesalamine	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59081	ORIG	2019-06-17