Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019081
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADERM ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
ESTRADERM ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None 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
09/10/1986 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-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019081Orig1s043ltr.pdf
07/03/2012 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019081s042ltr.pdf
12/17/2004 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081s040ltr.pdf
05/28/2004 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf
05/28/2004 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf
03/14/2002 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/20/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-31 Labeling

Label is not available on this site.

06/27/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1995 SUPPL-27 Labeling

Label is not available on this site.

11/28/1995 SUPPL-26 Labeling

Label is not available on this site.

01/20/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/18/1994 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/05/1993 SUPPL-22 Labeling

Label is not available on this site.

08/09/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1995 SUPPL-20 Labeling

Label is not available on this site.

01/22/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1991 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

06/12/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/19/1990 SUPPL-15 Labeling

Label is not available on this site.

06/18/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1990 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/03/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1988 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1988 SUPPL-8 Labeling

Label is not available on this site.

07/07/1987 SUPPL-7 Labeling

Label is not available on this site.

01/07/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/26/1987 SUPPL-2 Labeling

Label is not available on this site.

12/03/1986 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-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf
07/03/2012 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf
12/17/2004 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf
05/28/2004 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf
05/28/2004 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf

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