← FDA DRUG APPROVALS

FDA NDA · NDA020119

VUMON

Sponsor: HQ SPECLT PHARMA

APPLICATION
NDA020119
TYPE
NDA
ORIGINAL APPROVAL
1992-07-14
LATEST ACTION
2015-03-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VUMON · ReferenceDiscontinued
TENIPOSIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2015-03-02Labeling · Supplement 13 · standard — Letter ↗AP
2013-02-26Manufacturing (CMC) · Supplement 12 · priorityAP
2011-10-20Labeling · Supplement 11 · unknown — Label ↗AP
2011-10-20Labeling · Supplement 10 · standard — Letter ↗AP
2009-02-10Labeling · Supplement 9 · standard — Letter ↗AP
2002-10-01Labeling · Supplement 4 · standard — Letter ↗AP
2000-01-28Manufacturing (CMC) · Supplement 7 · priorityAP
1998-08-17Manufacturing (CMC) · Supplement 6 · priorityAP
1997-09-05Manufacturing (CMC) · Supplement 5 · priorityAP
1994-03-03Manufacturing (CMC) · Supplement 2 · priorityAP
1992-09-28Manufacturing (CMC) · Supplement 1 · priorityAP
1992-07-14Type 1 - New Molecular Entity · 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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