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FDA ANDA · ANDA076922

FLUOXETINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA076922
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-16
LATEST ACTION
2023-12-20
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
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL

Approval history

2023-12-20Labeling · Supplement 14 · standardAP
2023-12-20Labeling · Supplement 13 · standardAP
2023-12-20Labeling · Supplement 11 · standardAP
2015-12-17Labeling · Supplement 10 · standardAP
2014-09-16Labeling · Supplement 8 · standardAP
2012-02-28Labeling · Supplement 5AP
2012-02-28Labeling · Supplement 6AP
2010-03-25Labeling · Supplement 3AP
2010-03-25Labeling · Supplement 4AP
2008-09-25Labeling · Supplement 2AP
2005-09-15Labeling · Supplement 1AP
2004-12-16Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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