APPLICATION
ANDA210790
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-04
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LEVOMILNACIPRAN HYDROCHLORIDEDiscontinued
LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
LEVOMILNACIPRAN HYDROCHLORIDEDiscontinued
LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
LEVOMILNACIPRAN HYDROCHLORIDEDiscontinued
LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
LEVOMILNACIPRAN HYDROCHLORIDEDiscontinued
LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-07-23Labeling · Supplement 5 · standardAP
2025-07-23Labeling · Supplement 3 · standardAP
2025-07-23Labeling · Supplement 4 · standardAP
2023-01-27Labeling · Supplement 1 · standardAP
2023-01-27Labeling · Supplement 2 · 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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