APPLICATION
ANDA205071
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2026-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 50MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 12.5MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 100MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2026-04-14Labeling · Supplement 4 · standardAP
2026-04-14Labeling · Supplement 2 · standardAP
2026-04-14Labeling · Supplement 5 · standardAP
2016-01-27UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.