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FDA ANDA · ANDA078143

FLUOXETINE HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA078143
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-16
LATEST ACTION
2021-02-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2021-02-09Labeling · Supplement 4 · standardAP
2021-02-09Labeling · Supplement 3 · standardAP
2014-09-26Labeling · Supplement 2 · standardAP
2011-05-17Labeling · Supplement 1AP
2008-01-16Original — Other Important Information from FDA ↗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.

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