← FDA DRUG APPROVALS

FDA NDA · NDA204168

FETZIMA

levomilnacipran hydrochloride

Sponsor: ABBVIE

APPLICATION
NDA204168
TYPE
NDA
ORIGINAL APPROVAL
2013-07-25
LATEST ACTION
2024-04-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

FETZIMA · ReferencePrescription
LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
FETZIMA · ReferencePrescription
LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
FETZIMA · ReferencePrescription
LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
FETZIMA · ReferencePrescription
LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-04-19Labeling · Supplement 12 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 11 · standard — Label ↗AP
2023-03-24Efficacy · Supplement 10 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 7 · 901 required — Letter ↗AP
2019-10-07Efficacy · Supplement 6 · standard — Letter ↗AP
2017-12-19Labeling · Supplement 5 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 4 · 901 required — Label ↗AP
2015-06-05Manufacturing (CMC) · Supplement 3 · standardAP
2014-07-18Labeling · Supplement 2 · 901 required — Label ↗AP
2014-05-23Labeling · Supplement 1 · standard — Label ↗AP
2013-07-25Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
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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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