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FDA ANDA · ANDA075049

FLUOXETINE HYDROCHLORIDE

Sponsor: SENORES PHARMS

APPLICATION
ANDA075049
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-02
LATEST ACTION
2020-09-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2020-09-28Labeling · Supplement 36 · standardAP
2020-09-28Labeling · Supplement 42 · standardAP
2020-09-28Labeling · Supplement 40 · standardAP
2020-09-28Labeling · Supplement 39 · standardAP
2020-09-28Labeling · Supplement 35 · standardAP
2010-08-09Labeling · Supplement 32AP
2009-08-21Labeling · Supplement 30AP
2008-10-21Labeling · Supplement 27AP
2007-11-07Labeling · Supplement 23AP
2007-11-07Labeling · Supplement 21AP
2006-11-06Labeling · Supplement 20AP
2006-01-31Labeling · Supplement 19AP
2005-06-09Labeling · Supplement 14AP
2005-06-09Labeling · Supplement 17AP
2004-09-13Labeling · Supplement 12AP
2004-09-13Labeling · Supplement 13AP
2003-11-19Labeling · Supplement 11AP
2002-01-29Labeling · Supplement 8 — Letter ↗AP
2002-01-29Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2002-01-29Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2002-01-29Labeling · Supplement 10 — Letter ↗AP
2002-01-29Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2002-01-29Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2002-01-29Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2002-01-29Labeling · Supplement 3 — Letter ↗AP
2001-08-22Labeling · Supplement 1 — Letter ↗AP
2001-08-02Original — Letter ↗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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