FDA.reportPublic FDA data

Application 020699

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFFEXOR XRVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 37.5MG BASEYesNo
002EFFEXOR XRVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 75MG BASEYesNo
003EFFEXOR XRVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 100MG BASENoNo
004EFFEXOR XRVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0833EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0836EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0837EffexorVENLAFAXINE HYDROCHLORIDEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
21695-045Effexorvenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
21695-046Effexorvenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
21695-047Effexorvenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
21695-957Venlafaxine Hydrochloridevenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
21695-958Venlafaxine Hydrochloridevenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
21695-961Venlafaxine Hydrochloridevenlafaxine hydrochlorideRebel Distributors CorpNDACurrent
45865-643Venlafaxine Hydrochloridevenlafaxine hydrochlorideMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
45865-643Venlafaxine Hydrochloridevenlafaxine hydrochlorideMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
45865-647Venlafaxine Hydrochloridevenlafaxine hydrochlorideMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
45865-647Venlafaxine Hydrochloridevenlafaxine hydrochlorideMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
55289-277EffexorVENLAFAXINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-277EffexorVENLAFAXINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-277EffexorVENLAFAXINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-277EffexorVENLAFAXINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-277EffexorVENLAFAXINE HYDROCHLORIDEPD-Rx Pharmaceuticals, InNDACurrent
59762-0180Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0181Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0182Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGreenstone LLCNDA AUTHORIZED GENERICCurrent
61919-848VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEDIRECT RXNDACurrent
61919-848VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEDIRECT RXNDACurrent
61919-920VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
63187-223Venlafaxine Hydrochloridevenlafaxine hydrochlorideProficient Rx LPANDACurrent
63187-224Venlafaxine Hydrochloridevenlafaxine hydrochlorideProficient Rx LPANDACurrent
67544-189Effexorvenlafaxine hydrochlorideAphena Pharma Solutions - Tennessee, Inc.NDACurrent
68151-3659Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-3660Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
70518-2156EffexorVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.NDACurrent
70518-2157EffexorVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.NDACurrent
71610-013Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAphena Pharma Solutions -NDA AUTHORIZED Current
71610-013Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-018Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAphena Pharma Solutions -NDA AUTHORIZED Current
71610-018Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75255SUPPL 2023-08-22
75170SUPPL 2023-08-21
75160SUPPL 2023-08-21
71827SUPPL2022-08-17
71826SUPPL2022-08-17
71809SUPPL2022-08-16
69302SUPPL2021-11-12
69301SUPPL2021-11-12
69299SUPPL2021-11-12
68711SUPPL2021-09-21
68710SUPPL2021-09-21
68679SUPPL2021-09-21
50892SUPPL2017-12-27
50814SUPPL2017-12-21
50812SUPPL2017-12-21
50811SUPPL2017-12-21
50891SUPPL2017-12-20
47827SUPPL2017-04-03
47778SUPPL2017-03-30
46741SUPPL2017-01-10
46688SUPPL2017-01-06
13239SUPPL2016-03-03
3118SUPPL2016-03-02
25555SUPPL2014-12-19
13234SUPPL2014-12-19
25560SUPPL2014-10-23
25561SUPPL2014-07-09
25559SUPPL2014-07-09
35166SUPPL2014-07-08
13238SUPPL2014-07-08
13237SUPPL2012-12-28
13235SUPPL2012-12-28
25558SUPPL2012-12-21
25556SUPPL2012-12-21
35154SUPPL2012-09-11
13233SUPPL2012-09-11
25553SUPPL2012-08-28
25542SUPPL2012-08-28
25557SUPPL2012-05-09
13236SUPPL2012-05-07
25551SUPPL2010-01-19
25554SUPPL2010-01-14
35164SUPPL2010-01-08
20832ORIG2010-01-07
35162SUPPL2009-11-13
35163SUPPL2009-02-04
25552SUPPL2009-02-03
35161SUPPL2008-11-20
41568SUPPL2008-08-04
41564SUPPL2008-08-04
41562SUPPL2008-08-04
20833SUPPL2008-08-04
41576SUPPL2008-07-31
41574SUPPL2008-07-31
3117SUPPL2008-05-28
41571SUPPL2008-02-19
41569SUPPL2008-02-19
25550SUPPL2008-02-14
13232SUPPL2008-02-14
3112SUPPL2008-02-05
3105SUPPL2008-01-09
13226SUPPL2007-12-27
41578SUPPL2007-11-19
41577SUPPL2007-11-19
20840SUPPL2007-11-19
35160SUPPL2007-09-26
35159SUPPL2007-09-26
25549SUPPL2007-09-25
3116SUPPL2007-09-25
41563SUPPL2007-09-24
35158SUPPL2007-08-02
35155SUPPL2007-08-02
25548SUPPL2007-08-02
41575SUPPL2007-07-06
41573SUPPL2007-07-06
41572SUPPL2007-07-06
41570SUPPL2007-07-06
41567SUPPL2007-07-06
41566SUPPL2007-07-06
41565SUPPL2007-07-06
20838SUPPL2007-07-06
20837SUPPL2007-07-06
20836SUPPL2007-07-06
20835SUPPL2007-07-06
20834SUPPL2007-07-06
20839SUPPL2007-04-11
35156SUPPL2007-02-21
3113SUPPL2007-02-12
13231SUPPL2006-10-23
3115SUPPL2006-10-23
3114SUPPL2006-09-20
35157SUPPL2006-09-15
3111SUPPL2006-03-23
3108SUPPL2006-03-01
25547SUPPL2006-01-20
3110SUPPL2006-01-20
25546SUPPL2005-12-05
13230SUPPL2005-12-05
13229SUPPL2005-11-22
13228SUPPL2005-11-22