FDA.reportPublic FDA data

Application 004782

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREMARINESTROGENS, CONJUGATEDTABLET;ORAL1.25MGYesYes
002PREMARINESTROGENS, CONJUGATEDTABLET;ORAL2.5MGNoNo
003PREMARINESTROGENS, CONJUGATEDTABLET;ORAL0.3MGYesNo
004PREMARINESTROGENS, CONJUGATEDTABLET;ORAL0.625MGYesYes
005PREMARINESTROGENS, CONJUGATEDTABLET;ORAL0.9MGYesYes
006PREMARINESTROGENS, CONJUGATEDTABLET;ORAL0.45MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0046-1100Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1100Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1100Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1100Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1100Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1101Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1101Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1101Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1101Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1101Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1102Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1102Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1102Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1102Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1102Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1103Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1103Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1103Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1103Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1103Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1104Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1104Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1104Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1104Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1104Premarinestrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
43353-687Premarinconjugated estrogensAphena Pharma Solutions - Tennessee, Inc.NDACurrent
43353-688Premarinconjugated estrogensAphena Pharma Solutions - Tennessee, Inc.NDACurrent
50090-0167Premarinestrogens, conjugatedA-S Medication SolutionsNDACurrent
50090-0167Premarinestrogens, conjugatedA-S Medication SolutionsNDACurrent
50090-0167Premarinestrogens, conjugatedA-S Medication SolutionsNDACurrent
50090-0167Premarinestrogens, conjugatedA-S Medication SolutionsNDACurrent
50090-1853Premarinestrogens, conjugatedA-S Medication SolutionsNDACurrent
53808-0770Premarinconjugated estrogensState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82080SUPPL 2025-05-01
81995SUPPL 2025-04-25
77561SUPPL 2024-02-20
77514SUPPL 2024-02-16
63858SUPPL2020-07-13
50350SUPPL2017-11-09
32925SUPPL2014-12-10
10SUPPL2014-12-04
32924SUPPL2011-11-01
32923SUPPL2011-11-01
10673SUPPL2011-11-01
57SUPPL2011-10-31
9SUPPL2011-10-31
8SUPPL2011-10-31
43992ORIG2009-06-02
32922SUPPL2008-03-05
56SUPPL2008-03-05
40642SUPPL2007-04-09
20003SUPPL2007-04-09
7SUPPL2006-09-18
32921SUPPL2006-09-12
32920SUPPL2006-04-25
55SUPPL2006-04-25
10672SUPPL2005-11-03
6SUPPL2005-11-03
32919SUPPL2005-08-04
5SUPPL2005-08-04
32918SUPPL2005-04-12
10671SUPPL2005-04-12
54SUPPL2005-04-12
4SUPPL2005-04-12
10669SUPPL2004-11-17
10670SUPPL2004-08-31
53SUPPL2004-08-31
10668SUPPL2004-05-04
52SUPPL2004-04-29
51SUPPL2004-04-29
1SUPPL2003-07-28
49SUPPL2003-05-16
3SUPPL2003-05-16
32917SUPPL2003-04-30
10665SUPPL2003-04-28
10667SUPPL2003-01-07
50SUPPL2003-01-07
10666SUPPL2002-11-27
2SUPPL2002-11-27
40641SUPPL1998-09-08
48SUPPL1998-09-08