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FDA NDA · NDA021860

SARAFEM

Sponsor: APIL

APPLICATION
NDA021860
TYPE
NDA
ORIGINAL APPROVAL
2006-05-19
LATEST ACTION
2021-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SARAFEM · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SARAFEM · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SARAFEM · ReferenceDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-09-20Labeling · Supplement 15 · standard — Medication Guide ↗AP
2017-01-04Labeling · Supplement 11 · standard — Label ↗AP
2014-12-01Labeling · Supplement 10 · standard — Letter ↗AP
2013-07-05Labeling · Supplement 9 · unknown — Letter ↗AP
2013-07-05Labeling · Supplement 7 · standard — Label ↗AP
2013-07-05Labeling · Supplement 8 · unknown — Label ↗AP
2013-07-05Labeling · Supplement 6 · standard — Label ↗AP
2009-04-22Labeling · Supplement 5 · standard — Label ↗AP
2007-11-30Labeling · Supplement 2 · standard — Label ↗AP
2007-04-05Labeling · Supplement 1 · standard — Label ↗AP
2006-05-19Type 3 - New Dosage Form · Original · standard — Label ↗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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