Application 089590

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFASALAZINE	SULFASALAZINE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089590-001	SULFASALAZINE	SULFASALAZINE	500MG	TABLET / ORAL			1987-10-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089590-001	SULFASALAZINE	500MG	TABLET / ORAL	1987-10-19	`f41ea6bd6efb…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	257cee60-b68f-4c2b-b57d-8e4d73d17e09	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Azulfidine	SULFASALAZINE	Pfizer Laboratories Div Pfizer Inc	ddbe69f3-bd55-45f3-a64f-f60226c744c4	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: SULFASALAZINE
Azulfidine EN-tabs	SULFASALAZINE	Pfizer Laboratories Div Pfizer Inc	b9ef541a-93c8-4428-ba45-398aa0b327d1	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Sunrise Pharmaceutical, Inc.	d596ac59-b643-4181-80ba-f2db1cc3459c	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Rising Pharma Holdings, Inc.	3254432e-87a4-4af0-afd1-d9e6f1b0efd4	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Sunrise Pharmaceutical, Inc.	a54b31cc-205d-43d3-a850-acf4b41fbc37	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	A-S Medication Solutions	76b532a3-e7ca-4929-8c51-c0f66e0806a8	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	A-S Medication Solutions	32fd1726-ed81-4441-9594-3aecf2db1dbf	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Bryant Ranch Prepack	618c5324-d0a6-4d00-9b12-0de88a71c180	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Teva Pharmaceuticals USA, Inc.	3c59593b-e1a5-47cb-a82b-3e5e49205344	2023-08-22	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Aphena Pharma Solutions - Tennessee, LLC	bf5137fe-60ed-4497-8521-eeb0a684fabf	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE
Sulfasalazine	SULFASALAZINE	Chartwell RX, LLC.	029716bd-ee1a-484c-bf1f-ec8d02d5281b	2022-12-12	Warnings, Adverse reactions	Name fallback brand name: Sulfasalazine generic name: SULFASALAZINE

Reported adverse events (FAERS/openFDA)#

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