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FDA NDA · NDA021088

VIADUR

Sponsor: ORTHO MCNEIL JANSSEN

APPLICATION
NDA021088
TYPE
NDA
ORIGINAL APPROVAL
2000-03-03
LATEST ACTION
2011-01-14
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued

Products

VIADURDiscontinued
LEUPROLIDE ACETATE EQ 65MG BASE · IMPLANT · IMPLANTATION

Approval history

2011-01-14Labeling · Supplement 25 · standard — Label ↗AP
2005-09-15Labeling · Supplement 22 · standard — Label ↗AP
2005-09-08Labeling · Supplement 7 · standard — Label ↗AP
2003-08-01Labeling · Supplement 15 · standard — Letter ↗AP
2002-10-21Manufacturing (CMC) · Supplement 16 · standardAP
2002-08-23Manufacturing (CMC) · Supplement 13 · standardAP
2002-05-23Manufacturing (CMC) · Supplement 14 · standardAP
2002-05-23Manufacturing (CMC) · Supplement 12 · standardAP
2002-05-17Manufacturing (CMC) · Supplement 11 · standardAP
2001-08-13Manufacturing (CMC) · Supplement 8 · standardAP
2001-08-08Manufacturing (CMC) · Supplement 9 · standardAP
2001-07-05Manufacturing (CMC) · Supplement 6 · standardAP
2001-06-08Manufacturing (CMC) · Supplement 5 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 4 · standardAP
2000-10-16Manufacturing (CMC) · Supplement 3 · standardAP
2000-09-28Manufacturing (CMC) · Supplement 2 · standardAP
2000-09-18Manufacturing (CMC) · Supplement 1 · standardAP
2000-03-03Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
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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