Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020216
Company: WYETH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMARIN ESTROGENS, CONJUGATED 0.625MG/GM CREAM;TOPICAL, VAGINAL Prescription None 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
10/16/1978 ORIG-1 Approval UNKNOWN Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_original_approval.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020216Orig1s083ltr.pdf
12/28/2015 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020216Orig1s081ltr.pdf
09/25/2014 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/14/2012 SUPPL-75 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf
02/14/2012 SUPPL-74 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf
02/14/2012 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf
01/13/2010 SUPPL-69 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/22/2011 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020216s067ltr.pdf
11/07/2008 SUPPL-60 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020216Orig1s060.pdf
03/03/2008 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s059ltr.pdf
12/20/2007 SUPPL-56 Labeling

Label is not available on this site.

07/26/2006 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf
08/30/2005 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf
01/14/2005 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf
04/20/2004 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20216slr052ltr.pdf
05/08/2002 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/04/1998 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/14/1995 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1995 SUPPL-39 Labeling

Label is not available on this site.

08/30/1995 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1995 SUPPL-37 Labeling

Label is not available on this site.

02/06/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/14/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/14/1993 SUPPL-33 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s033_premarin_vaginal_cream.pdf
06/07/1990 SUPPL-31 Labeling

Label is not available on this site.

05/10/1990 SUPPL-30 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s030_premarin vaginal cream.pdf
02/12/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/17/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/17/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/17/1985 SUPPL-18 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s018_premarin vaginal cream.pdf
11/07/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/03/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/30/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/30/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/30/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/05/1982 SUPPL-6 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
11/01/2017 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf
12/28/2015 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf
02/14/2012 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf
02/14/2012 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf
02/14/2012 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf
04/22/2011 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf
11/07/2008 SUPPL-60 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf
03/03/2008 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf
07/26/2006 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf
08/30/2005 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf
01/14/2005 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf
04/20/2004 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf

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