FDA.reportPublic FDA data

Application 020882

Type
NDA
Sponsor
PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINTABLET;ORAL600MGYesNo
002NEURONTINGABAPENTINTABLET;ORAL800MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0401NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0513NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
59762-4355GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4355GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4355GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4355GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4355GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4460GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4460GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4460GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4460GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4460GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82119SUPPL 2025-05-01
82068SUPPL 2025-04-29
82067SUPPL 2025-04-29
79113SUPPL 2024-07-18
79099SUPPL 2024-07-15
65666SUPPL2020-12-21
65665SUPPL2020-12-21
65635SUPPL2020-12-21
65026SUPPL2020-10-26
62533SUPPL2020-04-10
62433SUPPL2020-04-03
50104SUPPL2017-10-19
47753SUPPL2017-03-29
47713SUPPL2017-03-27
47712SUPPL2017-03-27
35566SUPPL2015-09-23
26117SUPPL2015-09-17
35567SUPPL2015-04-27
26118SUPPL2015-04-22
35565SUPPL2014-08-20
26116SUPPL2014-08-20
35564SUPPL2013-05-09
35563SUPPL2013-05-09
13663SUPPL2013-05-09
26115SUPPL2013-05-07
26114SUPPL2013-05-07
3643SUPPL2013-05-07
26113SUPPL2011-08-12
13662SUPPL2011-08-11
3641SUPPL2011-03-07
35560SUPPL2011-03-04
3642SUPPL2010-10-13
35562SUPPL2010-10-11
26112SUPPL2009-05-01
35561SUPPL2009-04-28
24143ORIG2008-02-01
3640SUPPL2006-05-05
13661SUPPL2005-02-23
3639SUPPL2005-02-23
3638SUPPL2004-06-10
41780SUPPL2004-05-06
26111SUPPL2004-05-04
3637SUPPL2002-01-30
13660SUPPL2000-10-12
3636SUPPL2000-10-12
26110ORIG1998-10-09
21039ORIG1998-10-09