Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020908
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VAGIFEM ESTRADIOL 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;VAGINAL Discontinued None Yes No
VAGIFEM ESTRADIOL 10MCG TABLET;VAGINAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/26/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20908ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020908_000_VagifemTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2019 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020908s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020908Orig1s026ltr.pdf
11/01/2017 SUPPL-25 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf
03/01/2017 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020908Orig1s024ltr.pdf
04/04/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/27/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/11/2012 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020908s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020908s017ltr.pdf
05/17/2011 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020908s016ltr.pdf
11/25/2009 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf
11/06/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/06/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/17/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/11/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/09/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020908s026lbl.pdf
11/01/2017 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf
11/01/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf
03/01/2017 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s024lbl.pdf
04/11/2012 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020908s017lbl.pdf
11/25/2009 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf
03/26/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf

VAGIFEM

TABLET;VAGINAL; 10MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 10MCG TABLET;VAGINAL Prescription No AB 205256 AMNEAL PHARMS
ESTRADIOL ESTRADIOL 10MCG TABLET;VAGINAL Prescription No AB 210264 GLENMARK PHARMS LTD
ESTRADIOL ESTRADIOL 10MCG TABLET;VAGINAL Prescription No AB 206388 TEVA PHARMS USA
VAGIFEM ESTRADIOL 10MCG TABLET;VAGINAL Prescription Yes AB 020908 NOVO NORDISK INC

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