← FDA DRUG APPROVALS

FDA NDA · NDA012145

PROLIXIN

Sponsor: APOTHECON

APPLICATION
NDA012145
TYPE
NDA
ORIGINAL APPROVAL
1959-12-23
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued

Products

PROLIXIN · ReferenceDiscontinued
FLUPHENAZINE HYDROCHLORIDE 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ELIXIR · ORAL

Approval history

2007-12-07Labeling · Supplement 25AP
2007-12-07Labeling · Supplement 17AP
2007-12-07Labeling · Supplement 23AP
2007-12-07Labeling · Supplement 15AP
2007-12-07Labeling · Supplement 11AP
2007-12-07Labeling · Supplement 7AP
2007-12-07Labeling · Supplement 18AP
2007-12-07Labeling · Supplement 24AP
2007-12-07Labeling · Supplement 22AP
2007-12-07Labeling · Supplement 14AP
2002-07-12Manufacturing (CMC) · Supplement 27 · standardAP
1979-02-06Labeling · Supplement 16AP
1959-12-23Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →