APPLICATION
ANDA075690
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-31
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 9 · standardAP
2021-09-20Labeling · Supplement 8 · standardAP
2002-12-17Manufacturing (CMC) · Supplement 1AP
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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