← FDA DRUG APPROVALS

FDA NDA · NDA019557

ETOPOSIDE

Sponsor: ONESOURCE SPECIALTY

APPLICATION
NDA019557
TYPE
NDA
ORIGINAL APPROVAL
1986-12-30
LATEST ACTION
2002-11-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

VEPESID · ReferencePrescription
ETOPOSIDE 50MG · CAPSULE · ORAL
VEPESID · ReferenceDiscontinued
ETOPOSIDE 100MG · CAPSULE · ORAL

Approval history

2002-11-05Labeling · Supplement 28 · standard — Review ↗AP
2000-11-21Manufacturing (CMC) · Supplement 27 · priorityAP
2000-02-02Manufacturing (CMC) · Supplement 26 · priorityAP
1999-04-02Labeling · Supplement 23 · standard — Review ↗AP
1999-01-19Manufacturing (CMC) · Supplement 22 · priorityAP
1998-12-15Manufacturing (CMC) · Supplement 21 · priorityAP
1995-10-17Manufacturing (CMC) · Supplement 18 · priorityAP
1995-05-17Manufacturing (CMC) · Supplement 12 · priorityAP
1993-07-23Labeling · Supplement 15 · standardAP
1993-03-02Manufacturing (CMC) · Supplement 14 · priorityAP
1991-11-01Labeling · Supplement 9AP
1991-11-01Labeling · Supplement 10AP
1989-07-14Manufacturing (CMC) · Supplement 8 · priorityAP
1988-01-25Labeling · Supplement 6AP
1987-08-24Labeling · Supplement 5AP
1987-08-24Labeling · Supplement 4AP
1987-05-20Labeling · Supplement 3AP
1987-03-26Manufacturing (CMC) · Supplement 2 · priorityAP
1986-12-30Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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