← FDA DRUG APPROVALS

FDA NDA · NDA020457

ETOPOPHOS

etoposide phosphate

Sponsor: CHEPLAPHARM

APPLICATION
NDA020457
TYPE
NDA
ORIGINAL APPROVAL
1996-05-17
LATEST ACTION
2019-05-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ETOPOPHOS PRESERVATIVE FREE · ReferencePrescription
ETOPOSIDE PHOSPHATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2019-05-02Labeling · Supplement 19 · standard — Label ↗AP
2017-05-23Labeling · Supplement 16 · standard — Label ↗AP
2016-11-09Labeling · Supplement 15 · standard — Letter ↗AP
2015-07-30Labeling · Supplement 14 · standard — Letter ↗AP
2011-03-17Labeling · Supplement 13 · standard — Label ↗AP
2002-11-05Labeling · Supplement 6 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 3 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 4 · standard — Letter ↗AP
2001-12-21Labeling · Supplement 2 · standardAP
1999-08-16Manufacturing (CMC) · Supplement 5 · standardAP
1996-05-17Type 2 - New Active Ingredient · 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 →