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FDA ANDA · ANDA216232

FLUOXETINE

Sponsor: MICRO LABS

APPLICATION
ANDA216232
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-29
LATEST ACTION
2023-11-15
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

2023-11-15Labeling · Supplement 2 · standardAP
2022-03-29UNKNOWN · Original · standardAP
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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