FDA.reportPublic FDA data

Application 020990

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLOFTSERTRALINE HYDROCHLORIDECONCENTRATE;ORALEQ 20MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4940Zoloftsertraline hydrochlorideRoerigNDACurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75231SUPPL 2023-08-22
75210SUPPL 2023-08-22
75209SUPPL 2023-08-22
73312SUPPL2023-01-30
73311SUPPL2023-01-30
73293SUPPL2023-01-26
68707SUPPL2021-09-21
68706SUPPL2021-09-21
68674SUPPL2021-09-21
50723SUPPL2017-12-18
50722SUPPL2017-12-18
50669SUPPL2017-12-12
50668SUPPL2017-12-12
50667SUPPL2017-12-12
48747SUPPL2017-06-16
48726SUPPL2017-06-16
46552SUPPL2016-12-27
46551SUPPL2016-12-27
46550SUPPL2016-12-27
46537SUPPL2016-12-27
46536SUPPL2016-12-27
46535SUPPL2016-12-27
35840SUPPL2014-09-19
3996SUPPL2014-09-16
35839SUPPL2014-07-08
35838SUPPL2014-07-08
3995SUPPL2014-07-08
3994SUPPL2014-07-08
14121SUPPL2013-02-06
3993SUPPL2013-02-04
14122SUPPL2012-12-28
14119SUPPL2012-12-28
26428SUPPL2012-12-21
3992SUPPL2012-12-21
35837SUPPL2011-08-24
35836SUPPL2011-08-24
14120SUPPL2011-08-24
26427SUPPL2011-08-22
26426SUPPL2011-08-22
3991SUPPL2011-08-22
14118SUPPL2009-02-04
3990SUPPL2009-02-03
35835SUPPL2008-03-07
26425SUPPL2008-03-07
35834SUPPL2007-10-10
26424SUPPL2007-10-10
26422SUPPL2007-08-07
3989SUPPL2007-08-07
14117SUPPL2007-08-03
21334SUPPL2007-03-02
35833SUPPL2006-09-15
26423SUPPL2006-09-15
14116SUPPL2006-09-15
3988SUPPL2006-09-15
3987SUPPL2006-05-16
26421SUPPL2005-07-29
23616ORIG2005-07-29
14115SUPPL2005-07-14
14114SUPPL2005-07-14
26420SUPPL2005-02-23
3986SUPPL2005-02-23
35832SUPPL2004-08-25
26419SUPPL2004-08-25
14113SUPPL2004-08-25
3985SUPPL2004-08-25
26418SUPPL2004-07-01
35831SUPPL2003-09-25
26417SUPPL2003-09-25
3983SUPPL2003-07-31
26413SUPPL2003-07-23
35828SUPPL2003-04-25
14112SUPPL2003-03-05
3984SUPPL2002-09-20
26416SUPPL2002-09-18
35830SUPPL2002-05-16
26415SUPPL2002-05-16
35829SUPPL2001-08-17
26414SUPPL2001-08-17
21333SUPPL2001-08-17
26412ORIG1999-12-07
21332ORIG1999-12-07
14111ORIG1999-12-07