FDA.reportPublic FDA data

Application 020527

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATETABLET;ORAL-280.625MG;2.5MGYesYes
002PREMPHASE 14/14ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATETABLET;ORAL-280.625MG,0.625MG;N/A,5MGYesYes
003PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATETABLET;ORAL-280.625MG;5MGYesYes
004PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATETABLET;ORAL-280.45MG;1.5MGYesYes
005PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATETABLET;ORAL-280.3MG;1.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0046-1105PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1105Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1105PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1105Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1106Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1106PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1106Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1106PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1107Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1107PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1107Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1107PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1108Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1108PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1108Premproconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1108PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-2575Premphaseconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-2575Premphaseconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-2575Premphaseconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-2575Premphaseconjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
50090-0573PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEA-S Medication SolutionsNDACurrent
50090-0573Premproconjugated estrogens and medroxyprogesterone acetateA-S Medication SolutionsNDACurrent
68258-5978Premproconjugated estrogens and medroxyprogesterone acetateDispensing Solutions, Inc.NDACurrent
68258-5980Premproconjugated estrogens and medroxyprogesterone acetateDispensing Solutions, Inc.NDACurrent
69189-1107PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATEAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81985SUPPL 2025-04-24
77566SUPPL 2024-02-20
77541SUPPL 2024-02-16
50298SUPPL2017-11-06
50284SUPPL2017-11-03
34781SUPPL2015-09-04
2674SUPPL2015-09-04
20707SUPPL2013-01-24
25121SUPPL2012-02-07
2673SUPPL2012-02-07
2672SUPPL2012-02-07
2671SUPPL2012-02-07
34780SUPPL2012-02-06
34779SUPPL2012-02-06
34778SUPPL2012-02-06
12686SUPPL2012-02-06
41415SUPPL2011-01-07
41414SUPPL2011-01-07
20706SUPPL2011-01-07
25119SUPPL2010-01-06
34777SUPPL2010-01-04
12685SUPPL2009-06-05
23582ORIG2009-06-02
25120SUPPL2009-05-26
12684SUPPL2008-03-05
2670SUPPL2008-03-05
34776SUPPL2006-08-04
2669SUPPL2006-08-04
25118SUPPL2005-07-08
12683SUPPL2005-07-07
12682SUPPL2004-12-29
25117SUPPL2004-04-29
2668SUPPL2004-04-29
34775SUPPL2004-04-23
20705SUPPL2003-09-11
34774SUPPL2003-06-08
34772SUPPL2003-06-08
34771SUPPL2003-06-08
25115SUPPL2003-06-08
2667SUPPL2003-06-08
2665SUPPL2003-06-08
34770SUPPL2003-03-20
2664SUPPL2003-03-18
12681SUPPL2003-01-07
2666SUPPL2003-01-07
34773SUPPL2002-11-27
25116SUPPL2002-11-27
25114SUPPL2002-02-11
20704SUPPL1998-05-12
41413SUPPL1998-01-09
25113SUPPL1998-01-09
20703SUPPL1997-07-31