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FDA ANDA · ANDA078045

FLUOXETINE HYDROCHLORIDE

Sponsor: NATCO PHARMA USA

APPLICATION
ANDA078045
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-17
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-08-18Labeling · Supplement 12 · standardAP
2021-09-20Labeling · Supplement 10 · standardAP
2017-01-04Labeling · Supplement 9 · standardAP
2016-05-05Labeling · Supplement 8 · standardAP
2015-07-31Labeling · Supplement 7 · standardAP
2010-04-21Labeling · Supplement 3AP
2009-08-21Labeling · Supplement 1AP
2008-11-17Original — 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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