FDA.reportPublic FDA data

Application 021243

Type
NDA
Sponsor
PHARMACIA UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZULFIDINE EN-TABSSULFASALAZINETABLET; ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
brand name: Azulfidine EN-tabs
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEREMEDYREPACK INC.88441a9f-b4f9-455d-a355-46fb30699a7b2026-01-28Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.d596ac59-b643-4181-80ba-f2db1cc3459c2025-12-11Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINERising Pharma Holdings, Inc.3254432e-87a4-4af0-afd1-d9e6f1b0efd42025-11-06Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.a54b31cc-205d-43d3-a850-acf4b41fbc372025-09-15Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.257cee60-b68f-4c2b-b57d-8e4d73d17e092025-05-29Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.48fbc535-a33a-45ee-85ff-9d1ec9b31d9c2025-05-28Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE
SulfasalazineSULFASALAZINEChartwell RX, LLC.029716bd-ee1a-484c-bf1f-ec8d02d5281b2022-12-12Warnings, Adverse reactionsName fallback
generic name: SULFASALAZINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72639ORIG2022-11-17
72634ORIG2022-11-17
21534ORIG2010-10-15