← FDA DRUG APPROVALS

FDA NDA · NDA020538

VIVELLE-DOT

estradiol

Sponsor: SANDOZ

APPLICATION
NDA020538
TYPE
NDA
ORIGINAL APPROVAL
1996-07-31
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL, Transdermal
DOSAGE FORM
Film, Extended Release, SYSTEM
MARKETING STATUS
Discontinued, Prescription

Products

ESTRADIOLDiscontinued
ESTRADIOL 0.0375MG/24HR · Film, Extended Release · Transdermal
VIVELLE-DOT · ReferencePrescription
ESTRADIOL 0.1MG/24HR · SYSTEM · TRANSDERMAL
VIVELLE-DOT · ReferencePrescription
ESTRADIOL 0.05MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLDiscontinued
ESTRADIOL 0.1MG/24HR · Film, Extended Release · Transdermal
ESTRADIOLDiscontinued
ESTRADIOL 0.075MG/24HR · Film, Extended Release · Transdermal
VIVELLE-DOT · ReferencePrescription
ESTRADIOL 0.025MG/24HR · SYSTEM · TRANSDERMAL
VIVELLE-DOT · ReferencePrescription
ESTRADIOL 0.075MG/24HR · SYSTEM · TRANSDERMAL
VIVELLE-DOT · ReferencePrescription
ESTRADIOL 0.0375MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLDiscontinued
ESTRADIOL 0.05MG/24HR · Film, Extended Release · Transdermal

Approval history

2024-02-15Labeling · Supplement 43 · standard — Letter ↗AP
2021-10-04Labeling · Supplement 39 · standard — Label ↗AP
2021-10-04Labeling · Supplement 37 · standard — Label ↗AP
2021-09-01Labeling · Supplement 40 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 35 · standard — Label ↗AP
2015-09-01Manufacturing (CMC) · Supplement 33 · standardAP
2014-07-31Labeling · Supplement 32 · standard — Label ↗AP
2013-05-20Labeling · Supplement 28 · unknown — Letter ↗AP
2013-05-20Labeling · Supplement 30 · unknown — Label ↗AP
2013-05-20Labeling · Supplement 29 · unknown — Letter ↗AP
2013-04-24Manufacturing (CMC) · Supplement 31 · standardAP
2004-08-06Labeling · Supplement 24 · standard — Label ↗AP
2004-01-28Labeling · Supplement 19 · standard — Label ↗AP
2002-05-03Efficacy · Supplement 14 · standard — Letter ↗AP
2002-05-03Labeling · Supplement 12 · standard — Letter ↗AP
2002-05-03Efficacy · Supplement 15 · standard — Label ↗AP
2002-03-28Manufacturing (CMC) · Supplement 17 · standardAP
2002-02-22Manufacturing (CMC) · Supplement 16 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 13 · standardAP
2000-09-29Manufacturing (CMC) · Supplement 10 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 9 · standardAP
1999-07-30Manufacturing (CMC) · Supplement 7 · standardAP
1999-03-26Labeling · Supplement 8 · standardAP
1999-01-08Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
1997-09-26Manufacturing (CMC) · Supplement 5 · standardAP
1997-09-25Manufacturing (CMC) · Supplement 4 · standardAP
1997-09-23Manufacturing (CMC) · Supplement 3 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 2 · standardAP
1996-07-31Type 5 - New Formulation or New Manufacturer · 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 →