Tools / Drug approvals and letters / Drugs Vivelle NDA 20323, held by Sandoz . Estradiol
As of Nov 13, 2026, NDA 20323 (Vivelle), held by Sandoz, was first approved by FDA on Oct 28, 1994, with 33 approved supplements and 0 published complete response letters.
First approved : Oct 28, 1994 Review : Standard Supplements approved : 33 Complete response letters : 0
Approvals and New Uses The original application and every efficacy supplement, newest first; all 34 submissions below Date Submission Status Documents Feb 25, 2000 Supplement 21Efficacy (new indication or use) · Standard review Approved Review Letter Label Oct 28, 1994 Original applicationNew dosage form · Standard review Approved None posted
Products 5 strengths and forms Product Active ingredient Marketing Vivelle0.0375MG/24HR · system;transdermal Estradiol Discontinued Vivelle0.05MG/24HR · system;transdermal Estradiol Discontinued Vivelle0.075MG/24HR · system;transdermal Estradiol Discontinued Vivelle0.1MG/24HR · system;transdermal Estradiol Discontinued Vivelle0.025MG/24HR · system;transdermal Estradiol Discontinued
All 34 submissions, including labeling and manufacturing supplements Date Submission Status Documents Oct 30, 2026 Supplement 40Labeling · Standard review Approved Letter Letter Label Feb 15, 2024 Supplement 38Labeling · Standard review Approved Label Letter Nov 1, 2017 Supplement 36Labeling · Standard review Approved Letter Label Aug 6, 2004 Supplement 33Labeling · Standard review Approved Letter Label Jan 22, 2004 Supplement 30Labeling · Standard review Approved Label Letter Jan 22, 2004 Supplement 25Labeling · Standard review Approved Label Letter Jan 22, 2004 Supplement 17Labeling · Standard review Approved Label Letter Jul 18, 2002 Supplement 29Manufacturing · Standard review Approved None posted Mar 28, 2002 Supplement 28Manufacturing · Standard review Approved None posted Oct 31, 2001 Supplement 27Manufacturing · Standard review Approved None posted Jul 3, 2001 Supplement 26Manufacturing · Standard review Approved None posted Feb 1, 2001 Supplement 24Manufacturing · Standard review Approved None posted Aug 16, 2000 Supplement 23Labeling · Standard review Approved Review Label Letter Feb 25, 2000 Supplement 21Efficacy (new indication or use) · Standard review Approved Review Letter Label Oct 29, 1999 Supplement 22Manufacturing · Standard review Approved None posted Apr 1, 1999 Supplement 20Manufacturing · Standard review Approved None posted Oct 28, 1998 Supplement 18Manufacturing · Standard review Approved None posted Oct 27, 1998 Supplement 19Manufacturing · Standard review Approved None posted Jul 23, 1997 Supplement 16Manufacturing · Standard review Approved None posted Jul 22, 1997 Supplement 15Manufacturing · Standard review Approved None posted May 29, 1997 Supplement 14Labeling · Standard review Approved None posted Jan 9, 1997 Supplement 12Manufacturing · Standard review Approved None posted Jul 10, 1996 Supplement 13Manufacturing · Standard review Approved None posted Apr 10, 1996 Supplement 6Manufacturing · Standard review Approved None posted Feb 21, 1996 Supplement 11Manufacturing · Standard review Approved None posted Feb 21, 1996 Supplement 10Manufacturing · Standard review Approved None posted Dec 11, 1995 Supplement 8Labeling · Standard review Approved None posted Dec 7, 1995 Supplement 9Labeling · Standard review Approved None posted Oct 2, 1995 Supplement 3Labeling · Standard review Approved None posted Aug 9, 1995 Supplement 5Manufacturing · Standard review Approved None posted Jun 20, 1995 Supplement 4Manufacturing · Standard review Approved None posted Jun 9, 1995 Supplement 2Manufacturing · Standard review Approved None posted Mar 21, 1995 Supplement 1Manufacturing · Standard review Approved None posted Oct 28, 1994 Original applicationNew dosage form · Standard review Approved None posted
Identifiers
Application NDA 20323 Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
