FDA.reportPublic FDA data

Application 206909

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALSALAZIDE DISODIUMBALSALAZIDE DISODIUMTABLET;ORAL1.1GNoNo

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 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balsalazide DisodiumBALSALAZIDE DISODIUMApotex Corp.f12ffa32-d14b-e9d9-e957-2ef08b64e8b42026-09-09Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMAvPAK509b83b6-cde6-393b-8560-557793b6a5292025-12-30Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMZydus Lifesciences Limitedc573888c-4aa3-4fdb-bf3f-1cf3d78d922b2025-06-13Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMZydus Pharmaceuticals (USA) Inc.0ed73067-e2ca-4184-a93a-5a2141bb48982025-06-13Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMCarnegie Pharmaceuticals, LLC620f86cb-b6a2-4af8-a642-925dd8a1c5fe2025-04-15Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMBryant Ranch Prepackcd73c9f1-d83b-4206-b2c6-1bd111e112632025-04-02Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMGolden State Medical Supply, Inc.029833fa-ec5c-6a39-e063-6294a90aa0632025-02-18Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMHikma Pharmaceuticals USA Inc.a0498308-14b2-4456-8e13-795f6fc8ea302024-02-22Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM

Reported adverse events (FAERS/openFDA)#

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