Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020323
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIVELLE ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No 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
10/28/1994 ORIG-1 Approval Type 3 - New Dosage Form 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-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020323Orig1s036ltr.pdf
08/06/2004 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323s033ltr.pdf
01/22/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf
07/18/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/22/2004 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf
02/01/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/2000 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm
10/29/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/2000 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S21LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-323S021_Vivelle.cfm
04/01/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/28/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/22/2004 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf
07/23/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1997 SUPPL-14 Labeling

Label is not available on this site.

07/10/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/21/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1995 SUPPL-9 Labeling

Label is not available on this site.

12/11/1995 SUPPL-8 Labeling

Label is not available on this site.

04/10/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/09/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-3 Labeling

Label is not available on this site.

06/09/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1995 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-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf
08/06/2004 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf
01/22/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf
01/22/2004 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf
01/22/2004 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf
08/16/2000 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf
02/25/2000 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF

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