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FDA ANDA · ANDA076006

FLUOXETINE

Sponsor: DR REDDYS

APPLICATION
ANDA076006
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-30
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 12 · standardAP
2021-09-20Labeling · Supplement 9 · standardAP
2021-08-25Labeling · Supplement 8 · standardAP
2017-01-04Labeling · Supplement 6 · standardAP
2016-12-28Labeling · Supplement 5 · standardAP
2014-07-17Labeling · Supplement 4 · standardAP
2010-05-10Labeling · Supplement 3AP
2009-08-21Labeling · Supplement 2AP
2007-01-25Labeling · Supplement 1AP
2002-01-30Original — 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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