Duloxetine Hydrochloride (duloxetine hydrochloride)
New formulation or manufacturer
- Region
- 🇺🇸 US
- Active substance
- duloxetine hydrochloride
- Company
- Almatica
- Status
- Approved
- FDA approval
- Fri 27 Feb 2026
- Designations
- New formulation or manufacturer
- Application
- NDA219131
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 27 Feb 2026🇺🇸 FDA approval
FDA approves Duloxetine Hydrochloride (duloxetine hydrochloride): new formulation or manufacturer
Almatica; NDA219131; New formulation or manufacturer; capsule, delayed rel pellets · 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.