← FDA DRUG APPROVALS

FDA ANDA · ANDA078619

FLUOXETINE

fluoxetine hydrochloride

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078619
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-31
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-07-11Manufacturing (CMC) · Supplement 29 · unknownAP
2024-03-05Labeling · Supplement 28 · standardAP
2024-03-05Labeling · Supplement 24 · standardAP
2024-03-05Labeling · Supplement 14 · standardAP
2024-03-05Labeling · Supplement 27 · standardAP
2024-03-05Labeling · Supplement 17 · standardAP
2024-03-05Labeling · Supplement 15 · standardAP
2024-03-05Labeling · Supplement 13 · standardAP
2016-03-14Labeling · Supplement 12 · standardAP
2016-03-14Labeling · Supplement 10 · standardAP
2016-03-14Labeling · Supplement 8 · standardAP
2016-03-14Labeling · Supplement 11 · standardAP
2014-02-24Manufacturing (CMC) · Supplement 5AP
2012-02-28Labeling · Supplement 7AP
2011-01-13Manufacturing (CMC) · Supplement 4AP
2010-06-25Labeling · Supplement 3AP
2009-03-06Labeling · Supplement 2AP
2008-09-25Labeling · Supplement 1AP
2008-01-31Original — 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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