← FDA DRUG APPROVALS

FDA NDA · NDA020323

VIVELLE

Sponsor: SANDOZ

APPLICATION
NDA020323
TYPE
NDA
ORIGINAL APPROVAL
1994-10-28
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Discontinued

Products

VIVELLEDiscontinued
ESTRADIOL 0.1MG/24HR · SYSTEM · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.05MG/24HR · SYSTEM · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.025MG/24HR · SYSTEM · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.075MG/24HR · SYSTEM · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.0375MG/24HR · SYSTEM · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 38 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 36 · standard — Label ↗AP
2004-08-06Labeling · Supplement 33 · standard — Letter ↗AP
2004-01-22Labeling · Supplement 30 · standard — Letter ↗AP
2004-01-22Labeling · Supplement 25 · standard — Letter ↗AP
2004-01-22Labeling · Supplement 17 · standard — Letter ↗AP
2002-07-18Manufacturing (CMC) · Supplement 29 · standardAP
2002-03-28Manufacturing (CMC) · Supplement 28 · standardAP
2001-10-31Manufacturing (CMC) · Supplement 27 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 26 · standardAP
2001-02-01Manufacturing (CMC) · Supplement 24 · standardAP
2000-08-16Labeling · Supplement 23 · standard — Label ↗AP
2000-02-25Efficacy · Supplement 21 · standard — Review ↗AP
1999-10-29Manufacturing (CMC) · Supplement 22 · standardAP
1999-04-01Manufacturing (CMC) · Supplement 20 · standardAP
1998-10-28Manufacturing (CMC) · Supplement 18 · standardAP
1998-10-27Manufacturing (CMC) · Supplement 19 · standardAP
1997-07-23Manufacturing (CMC) · Supplement 16 · standardAP
1997-07-22Manufacturing (CMC) · Supplement 15 · standardAP
1997-05-29Labeling · Supplement 14 · standardAP
1997-01-09Manufacturing (CMC) · Supplement 12 · standardAP
1996-07-10Manufacturing (CMC) · Supplement 13 · standardAP
1996-04-10Manufacturing (CMC) · Supplement 6 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 11 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 10 · standardAP
1995-12-11Labeling · Supplement 8 · standardAP
1995-12-07Labeling · Supplement 9 · standardAP
1995-10-02Labeling · Supplement 3 · standardAP
1995-08-09Manufacturing (CMC) · Supplement 5 · standardAP
1995-06-20Manufacturing (CMC) · Supplement 4 · standardAP
1995-06-09Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-21Manufacturing (CMC) · Supplement 1 · standardAP
1994-10-28Type 3 - New Dosage Form · 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 →