Home Applications 206909 Application 206909
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM TABLET;ORAL 1.1G No No
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 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Balsalazide Disodium BALSALAZIDE DISODIUM Apotex Corp. f12ffa32-d14b-e9d9-e957-2ef08b64e8b4 2026-09-09 Warnings, Adverse reactions Name fallback brand name: Balsalazide Disodium generic name: BALSALAZIDE DISODIUM Balsalazide Disodium BALSALAZIDE DISODIUM AvPAK 509b83b6-cde6-393b-8560-557793b6a529 2025-12-30 Warnings, Adverse reactions Name fallback brand name: Balsalazide Disodium generic name: BALSALAZIDE DISODIUM Balsalazide Disodium BALSALAZIDE DISODIUM PD-Rx Pharmaceuticals, Inc. b3ecc533-dd55-4a2f-84c4-ecd454aae766 2025-10-08 Warnings, Adverse reactions Name fallback brand name: Balsalazide Disodium generic name: BALSALAZIDE DISODIUM balsalazide disodium BALSALAZIDE DISODIUM Zydus Lifesciences Limited c573888c-4aa3-4fdb-bf3f-1cf3d78d922b 2025-06-13 Warnings, Adverse reactions Name fallback brand name: balsalazide disodium generic name: BALSALAZIDE DISODIUM balsalazide disodium BALSALAZIDE DISODIUM Zydus Pharmaceuticals (USA) Inc. 0ed73067-e2ca-4184-a93a-5a2141bb4898 2025-06-13 Warnings, Adverse reactions Name fallback brand name: balsalazide disodium generic name: BALSALAZIDE DISODIUM balsalazide disodium BALSALAZIDE DISODIUM Carnegie Pharmaceuticals, LLC 620f86cb-b6a2-4af8-a642-925dd8a1c5fe 2025-04-15 Warnings, Adverse reactions Name fallback brand name: balsalazide disodium generic name: BALSALAZIDE DISODIUM Balsalazide Disodium BALSALAZIDE DISODIUM Bryant Ranch Prepack cd73c9f1-d83b-4206-b2c6-1bd111e11263 2025-04-02 Warnings, Adverse reactions Name fallback brand name: Balsalazide Disodium generic name: BALSALAZIDE DISODIUM Balsalazide Disodium BALSALAZIDE DISODIUM Golden State Medical Supply, Inc. 029833fa-ec5c-6a39-e063-6294a90aa063 2025-02-18 Warnings, Adverse reactions Name fallback brand name: Balsalazide Disodium generic name: BALSALAZIDE DISODIUM Balsalazide Disodium BALSALAZIDE DISODIUM Hikma Pharmaceuticals USA Inc. a0498308-14b2-4456-8e13-795f6fc8ea30 2024-02-22 Warnings, Adverse reactions Name 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.