← FDA DRUG APPROVALS

FDA NDA · NDA202133

FLUOXETINE HYDROCHLORIDE

Sponsor: TWI PHARMS

APPLICATION
NDA202133
TYPE
NDA
ORIGINAL APPROVAL
2011-10-06
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLUOXETINE HYDROCHLORIDE · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 16 · standard — Medication Guide ↗AP
2023-08-18Labeling · Supplement 9 · standard — Label ↗AP
2021-09-20Labeling · Supplement 12 · 901 required — Letter ↗AP
2017-01-04Labeling · Supplement 4 · standard — Label ↗AP
2017-01-04Labeling · Supplement 5 · 901 required — Label ↗AP
2014-07-18Labeling · Supplement 3 · 901 required — Label ↗AP
2011-10-06Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →