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Rocuronium Bromide (rocuronium bromide)

New formulation or manufacturer
Region
🇺🇸 US
Active substance
rocuronium bromide
Company
B Braun Medical
Status
Approved
FDA approval
Fri 24 Oct 2025
Designations
New formulation or manufacturer
Application
NDA219108
Official record
www.accessdata.fda.gov

Regulatory milestones

Fri 24 Oct 2025🇺🇸 FDA approval

FDA approves Rocuronium Bromide (rocuronium bromide): new formulation or manufacturer

B Braun Medical; NDA219108; New formulation or manufacturer; solution · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.