FDA.reportPublic FDA data

Application 087197

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFASALAZINESULFASALAZINETABLET;ORAL500MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087197-001SULFASALAZINESULFASALAZINE500MGTABLET / ORALApproved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A087197-001SULFASALAZINE500MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087197-001SULFASALAZINE500MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087197-001SULFASALAZINE500MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087197-001SULFASALAZINE500MGTABLET / ORALApproved before 1982a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.257cee60-b68f-4c2b-b57d-8e4d73d17e092026-08-25Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.48fbc535-a33a-45ee-85ff-9d1ec9b31d9c2026-08-25Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
AzulfidineSULFASALAZINEPfizer Laboratories Div Pfizer Incddbe69f3-bd55-45f3-a64f-f60226c744c42026-05-29Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
Azulfidine EN-tabsSULFASALAZINEPfizer Laboratories Div Pfizer Incb9ef541a-93c8-4428-ba45-398aa0b327d12026-05-29Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.d596ac59-b643-4181-80ba-f2db1cc3459c2025-12-11Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINERising Pharma Holdings, Inc.3254432e-87a4-4af0-afd1-d9e6f1b0efd42025-11-06Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.a54b31cc-205d-43d3-a850-acf4b41fbc372025-09-15Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEChartwell RX, LLC.029716bd-ee1a-484c-bf1f-ec8d02d5281b2022-12-12Warnings, Adverse reactionsName fallback
brand name: Sulfasalazine
generic name: SULFASALAZINE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-9021SULFASALAZINESULFASALAZINEPreferred PharmaceuticalsANDACurrent
68788-9021SULFASALAZINESULFASALAZINEPreferred Pharmaceuticals, IncANDACurrent