FDA.reportPublic FDA data

Application 020235

Type
NDA
Sponsor
PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINCAPSULE;ORAL100MGYesNo
002NEURONTINGABAPENTINCAPSULE;ORAL300MGYesNo
003NEURONTINGABAPENTINCAPSULE;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0803NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-0805NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-0806NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
59762-4030GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4030GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4030GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4030GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4030GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4135GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4135GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4135GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4135GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4135GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4240GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4240GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4240GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4240GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4240GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
70518-1382NeurontingabapentinREMEDYREPACK INC.NDACurrent
70518-1382NeurontingabapentinREMEDYREPACK INC.NDACurrent
70518-1405NeurontingabapentinREMEDYREPACK INC.NDACurrent
70518-1405NeurontingabapentinREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82118SUPPL 2025-05-01
82066SUPPL 2025-04-29
82065SUPPL 2025-04-25
79102SUPPL 2024-07-16
79098SUPPL 2024-07-15
65664SUPPL2020-12-21
65663SUPPL2020-12-21
65633SUPPL2020-12-21
62532SUPPL2020-04-10
62432SUPPL2020-04-03
50123SUPPL2017-10-20
50105SUPPL2017-10-19
47754SUPPL2017-03-29
47711SUPPL2017-03-27
47710SUPPL2017-03-27
12348SUPPL2015-09-23
2220SUPPL2015-09-17
24627SUPPL2015-05-11
34408SUPPL2015-04-27
34407SUPPL2014-08-20
2219SUPPL2014-08-20
34406SUPPL2013-05-09
34405SUPPL2013-05-09
12347SUPPL2013-05-09
24626SUPPL2013-05-07
24625SUPPL2013-05-07
2218SUPPL2013-05-07
2217SUPPL2011-08-12
34404SUPPL2011-08-11
24623SUPPL2011-03-07
12345SUPPL2011-03-04
24624SUPPL2010-10-13
12346SUPPL2010-10-11
2216SUPPL2009-05-01
34403SUPPL2009-04-28
2215SUPPL2006-05-05
12344SUPPL2005-02-23
2214SUPPL2005-02-23
2213SUPPL2004-06-10
41221SUPPL2004-05-06
2212SUPPL2002-01-30
24622SUPPL2000-10-12
12343SUPPL2000-10-12
41220SUPPL1998-09-29
34402SUPPL1998-09-29
24621SUPPL1998-09-29