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Flavalta (epinephrine bitartrate, lidocaine hydrochloride)

New formulation or manufacturer
Region
🇺🇸 US
Active substance
epinephrine bitartrate, lidocaine hydrochloride
Company
Deproco
Status
Approved
FDA approval
Thu 19 Mar 2026
Designations
New formulation or manufacturer
Application
NDA216564
Official record
www.accessdata.fda.gov

Regulatory milestones

Thu 19 Mar 2026🇺🇸 FDA approval

FDA approves Flavalta (epinephrine bitartrate, lidocaine hydrochloride): new formulation or manufacturer

Deproco; NDA216564; 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.