Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 004782
Company: WYETH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMARIN ESTROGENS, CONJUGATED 1.25MG TABLET;ORAL Prescription None Yes Yes
PREMARIN ESTROGENS, CONJUGATED 2.5MG TABLET;ORAL Discontinued None No No
PREMARIN ESTROGENS, CONJUGATED 0.3MG TABLET;ORAL Prescription None Yes No
PREMARIN ESTROGENS, CONJUGATED 0.625MG TABLET;ORAL Prescription None Yes Yes
PREMARIN ESTROGENS, CONJUGATED 0.9MG TABLET;ORAL Prescription None Yes Yes
PREMARIN ESTROGENS, CONJUGATED 0.45MG TABLET;ORAL Prescription 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
05/08/1942 ORIG-1 Approval Type 1 - New Molecular Entity 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
11/07/2017 SUPPL-176 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/004782Orig1s176ltr.pdf
09/01/2015 SUPPL-173 Manufacturing (CMC)

Label is not available on this site.

06/09/2015 SUPPL-172 Manufacturing (CMC)

Label is not available on this site.

12/03/2014 SUPPL-171 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf
10/28/2011 SUPPL-167 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf
10/28/2011 SUPPL-164 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf
04/11/2014 SUPPL-163 Manufacturing (CMC)

Label is not available on this site.

10/28/2011 SUPPL-162 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf
03/03/2008 SUPPL-155 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf
09/05/2006 SUPPL-147 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf
04/24/2006 SUPPL-146 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf
11/01/2005 SUPPL-142 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf
08/01/2005 SUPPL-141 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf
04/07/2005 SUPPL-139 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf
04/07/2005 SUPPL-138 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf
08/26/2004 SUPPL-137 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf
04/20/2004 SUPPL-136 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf
04/20/2004 SUPPL-133 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf
04/24/2003 SUPPL-130 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf
01/07/2003 SUPPL-129 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf
11/27/2002 SUPPL-128 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf
12/20/2002 SUPPL-126 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/2003 SUPPL-125 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf
08/21/2002 SUPPL-124 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/2001 SUPPL-121 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/2001 SUPPL-120 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/2001 SUPPL-116 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/24/2003 SUPPL-115 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf
07/05/2000 SUPPL-113 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1999 SUPPL-109 Labeling

Label is not available on this site.

10/29/1998 SUPPL-108 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1998 SUPPL-104 Labeling

Label is not available on this site.

06/28/1996 SUPPL-103 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1996 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1998 SUPPL-101 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1995 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1995 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1995 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1998 SUPPL-96 Labeling

Label is not available on this site.

02/06/1995 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

11/09/1994 SUPPL-94 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1998 SUPPL-93 Efficacy-New Dosing Regimen Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093.cfm
12/23/1993 SUPPL-92 Labeling

Label is not available on this site.

03/11/1992 SUPPL-87 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1999 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1990 SUPPL-83 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/22/1989 SUPPL-81 Labeling

Label is not available on this site.

05/19/1989 SUPPL-79 Labeling

Label is not available on this site.

05/09/1991 SUPPL-78 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/14/1991 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1989 SUPPL-75 Labeling

Label is not available on this site.

02/03/1989 SUPPL-74 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/20/1988 SUPPL-73 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/19/1989 SUPPL-72 Labeling

Label is not available on this site.

04/17/1988 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/16/1987 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1986 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

12/03/1986 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1989 SUPPL-64 Labeling

Label is not available on this site.

07/10/1986 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1986 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1989 SUPPL-61 Labeling

Label is not available on this site.

01/07/1986 SUPPL-60 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/25/1985 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1985 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1986 SUPPL-57 Labeling

Label is not available on this site.

04/29/1985 SUPPL-54 Labeling

Label is not available on this site.

04/29/1985 SUPPL-53 Labeling

Label is not available on this site.

05/29/1985 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1985 SUPPL-51 Labeling

Label is not available on this site.

05/29/1985 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/26/1984 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2014 SUPPL-171 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf
10/28/2011 SUPPL-167 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
10/28/2011 SUPPL-164 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
10/28/2011 SUPPL-162 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
03/03/2008 SUPPL-155 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf
09/05/2006 SUPPL-147 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf
04/24/2006 SUPPL-146 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf
11/01/2005 SUPPL-142 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf
08/01/2005 SUPPL-141 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf
04/07/2005 SUPPL-139 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
04/07/2005 SUPPL-138 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
08/26/2004 SUPPL-137 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf
04/20/2004 SUPPL-136 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf
04/20/2004 SUPPL-133 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf
04/24/2003 SUPPL-130 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
04/24/2003 SUPPL-115 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
01/07/2003 SUPPL-129 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf
11/27/2002 SUPPL-128 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf

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