← FDA DRUG APPROVALS

FDA NDA · NDA203479

VERSACLOZ

clozapine

Sponsor: DOUGLAS PHARMS

APPLICATION
NDA203479
TYPE
NDA
ORIGINAL APPROVAL
2013-02-06
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

VERSACLOZ · ReferencePrescription
CLOZAPINE 50MG/ML · SUSPENSION · ORAL

Approval history

2025-06-13REMS · Supplement 26 — Letter ↗AP
2025-01-22Labeling · Supplement 22 · standard — Label ↗AP
2023-04-26Labeling · Supplement 21 · standard — Label ↗AP
2021-11-10REMS · Supplement 17 — Letter ↗AP
2021-07-29REMS · Supplement 16 — Letter ↗AP
2021-02-18REMS · Supplement 15 — Letter ↗AP
2020-07-29Labeling · Supplement 12 · standard — Letter ↗AP
2020-04-14Labeling · Supplement 14 · 901 required — Label ↗AP
2019-01-16REMS · Supplement 11 — Letter ↗AP
2017-02-23Labeling · Supplement 10 · 901 required — Label ↗AP
2016-02-18Manufacturing (CMC) · Supplement 6 · standardAP
2015-09-30Labeling · Supplement 9 · standard — Label ↗AP
2015-09-15REMS · Supplement 8 — Label ↗AP
2015-09-15Labeling · Supplement 7 · standard — Letter ↗AP
2014-09-29Manufacturing (CMC) · Supplement 5 · standardAP
2014-03-25Manufacturing (CMC) · Supplement 4 · standardAP
2013-12-05REMS · Supplement 1 — Letter ↗AP
2013-08-22Labeling · Supplement 2 · standard — Letter ↗AP
2013-02-06Type 3 - New Dosage Form · Original · standard — Label ↗AP
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 →