APPLICATION
ANDA075292
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-07
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 24 · standardAP
2023-08-09Labeling · Supplement 23 · standardAP
2021-09-20Labeling · Supplement 21 · standardAP
2021-09-12Labeling · Supplement 20 · standardAP
2017-01-04Labeling · Supplement 19 · standardAP
2014-09-02Labeling · Supplement 18 · standardAP
2012-05-29Labeling · Supplement 17AP
2008-12-02Labeling · Supplement 15AP
2007-06-29Labeling · Supplement 12AP
2007-06-29Labeling · Supplement 11AP
2006-08-29Labeling · Supplement 10AP
2006-08-29Labeling · Supplement 9AP
2006-03-15Labeling · Supplement 7AP
2005-05-17Labeling · Supplement 4AP
2005-05-17Labeling · Supplement 5AP
2002-09-03Manufacturing (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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