Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020538
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.0375MG/24HR Film, Extended Release; Transdermal Discontinued None No No
ESTRADIOL ESTRADIOL 0.075MG/24HR Film, Extended Release; Transdermal Discontinued None No No
ESTRADIOL ESTRADIOL 0.05MG/24HR Film, Extended Release; Transdermal Discontinued None No No
ESTRADIOL ESTRADIOL 0.1MG/24HR Film, Extended Release; Transdermal Discontinued None No No
VIVELLE-DOT ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes No
VIVELLE-DOT ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes No
VIVELLE-DOT ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes No
VIVELLE-DOT ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes Yes
VIVELLE-DOT ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/1996 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf
09/01/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/31/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020538Orig1s032ltr.pdf
04/24/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/20/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf
05/20/2013 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf
05/20/2013 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf
08/06/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538s024ltr.pdf
01/28/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538slr019ltr.pdf
03/28/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2002 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020538_s015_VivelleTOC.cfm
05/03/2002 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf
07/09/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/03/2002 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf
09/29/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1999 SUPPL-8 Labeling

Label is not available on this site.

07/30/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1999 SUPPL-6 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538S6.cfm
09/26/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/25/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf
07/31/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf
05/20/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
05/20/2013 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
05/20/2013 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
08/06/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf
01/28/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf
05/03/2002 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
05/03/2002 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
05/03/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
01/08/1999 SUPPL-6 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf

ESTRADIOL

There are no Therapeutic Equivalents.

VIVELLE-DOT

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
VIVELLE-DOT ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020538 NOVARTIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
VIVELLE-DOT ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020538 NOVARTIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
VIVELLE-DOT ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020538 NOVARTIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
VIVELLE-DOT ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020538 NOVARTIS

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
VIVELLE-DOT ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020538 NOVARTIS

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