FDA.reportPublic FDA data

Application 021992

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRISTIQDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASEYesYes
002PRISTIQDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG BASEYesYes
003PRISTIQDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-1210Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1210Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1210Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1210Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1210Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1211Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1211Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1211Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1211Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1211Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1222Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1222Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1222Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1222Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1222Pristiqdesvenlafaxine succinateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
35356-491Pristiqdesvenlafaxine succinateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-262Pristiqdesvenlafaxine succinatePD-Rx Pharmaceuticals, Inc.NDACurrent
50090-4069Desvenlafaxine Succinatedesvenlafaxine succinateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
55154-4230Pristiqdesvenlafaxine succinateCardinal HealthNDACurrent
55154-4235Pristiqdesvenlafaxine succinateCardinal HealthNDACurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1210Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1211Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1222Desvenlafaxine Succinatedesvenlafaxine succinateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75246SUPPL 2023-08-22
75190SUPPL 2023-08-21
69304SUPPL2021-11-12
69303SUPPL2021-11-12
69295SUPPL2021-11-12
68699SUPPL2021-09-21
68698SUPPL2021-09-21
68694SUPPL2021-09-21
52517SUPPL2018-02-08
52429SUPPL2018-02-06
50899SUPPL2017-12-27
50801SUPPL2017-12-21
50800SUPPL2017-12-21
46689SUPPL2017-01-06
45174SUPPL2016-08-26
45061SUPPL2016-08-26
38026SUPPL2014-11-17
29005SUPPL2014-11-14
38027SUPPL2014-07-29
6623SUPPL2014-07-21
38025SUPPL2013-12-24
29004SUPPL2013-12-24
6619SUPPL2013-12-13
38021SUPPL2013-12-11
6622SUPPL2013-03-15
38024SUPPL2013-02-20
38022SUPPL2013-02-20
6620SUPPL2013-02-19
6621SUPPL2012-12-11
38023SUPPL2012-12-10
29003SUPPL2012-03-12
38020SUPPL2012-03-09
6618SUPPL2011-04-13
16713SUPPL2011-04-11
16712SUPPL2011-03-07
6617SUPPL2011-03-07
29002SUPPL2011-02-03
16711SUPPL2011-01-31
6616SUPPL2011-01-25
16710SUPPL2011-01-10
29000SUPPL2010-10-20
16707SUPPL2010-10-18
16709SUPPL2010-09-10
6615SUPPL2010-09-09
29001SUPPL2010-07-14
16708SUPPL2010-07-12
6614SUPPL2010-02-22
38019SUPPL2010-02-17
28999SUPPL2010-01-25
6613SUPPL2010-01-25
28998SUPPL2009-11-24
28995SUPPL2009-11-24
6612SUPPL2009-11-24
38018SUPPL2009-11-17
16705SUPPL2009-11-05
38017SUPPL2009-09-18
16706SUPPL2009-09-18
28997SUPPL2009-04-29
38016SUPPL2009-04-28
38015SUPPL2009-02-04
28996SUPPL2009-02-03
42371ORIG2008-06-13
38014ORIG2008-03-05
6611ORIG2008-03-05
54152SUPPL1900-01-01
54151SUPPL1900-01-01
54150SUPPL1900-01-01
54149SUPPL1900-01-01