← FDA DRUG APPROVALS

FDA ANDA · ANDA075464

FLUOXETINE HYDROCHLORIDE

Sponsor: LANDELA PHARM

APPLICATION
ANDA075464
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-30
LATEST ACTION
2011-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2011-07-11Labeling · Supplement 6AP
2011-05-31Labeling · Supplement 7AP
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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