APPLICATION
ANDA205081
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-22
LATEST ACTION
2026-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 100MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 25MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 50MG · TABLET · ORAL
MILNACIPRAN HYDROCHLORIDEPrescription
MILNACIPRAN HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
2026-04-14Labeling · Supplement 10 · standardAP
2025-03-13Labeling · Supplement 7 · standardAP
2025-03-13Labeling · Supplement 8 · standardAP
2024-02-29Labeling · Supplement 5 · standardAP
2024-02-29Labeling · Supplement 1 · standardAP
2024-02-29Labeling · Supplement 6 · standardAP
2024-02-29Labeling · Supplement 4 · standardAP
2016-04-22UNKNOWN · 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.
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