Javadin (clonidine hydrochloride)

New dosage form

Region: 🇺🇸 US
Active substance: clonidine hydrochloride
Company: Azurity
Status: Approved
FDA approval: Thu 23 Oct 2025
Designations: New dosage form
Application: NDA220256
Official record: www.accessdata.fda.gov

Regulatory milestones

Thu 23 Oct 2025🇺🇸 FDA approval

FDA approves Javadin (clonidine hydrochloride): new dosage form

Azurity; NDA220256; New dosage form; solution · source

Same substance in other markets

🇺🇸 Brytly Approved · Alcon Labs Inc
🇺🇸 Qlonilik Approved · Cmp Dev Llc

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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.