FDA.reportPublic FDA data

Application 021129

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINSOLUTION;ORAL250MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of PfizerNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
0071-2012NeurontingabapentinParke-Davis Div of Pfizer IncNDACurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5025GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5050GABAPENTINgabapentinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82120SUPPL 2025-05-01
82070SUPPL 2025-04-29
82069SUPPL 2025-04-29
79111SUPPL 2024-07-18
79097SUPPL 2024-07-15
65668SUPPL2020-12-21
65667SUPPL2020-12-21
65636SUPPL2020-12-21
62534SUPPL2020-04-10
62434SUPPL2020-04-03
50124SUPPL2017-10-20
50103SUPPL2017-10-19
47752SUPPL2017-03-29
47715SUPPL2017-03-27
47714SUPPL2017-03-27
14451SUPPL2015-09-23
4402SUPPL2015-09-17
36169SUPPL2015-04-27
4403SUPPL2015-04-22
14450SUPPL2014-08-20
4401SUPPL2014-08-20
36168SUPPL2013-05-09
36167SUPPL2013-05-09
14449SUPPL2013-05-09
26842SUPPL2013-05-07
4400SUPPL2013-05-07
4399SUPPL2013-05-07
4398SUPPL2011-08-12
36166SUPPL2011-08-11
4397SUPPL2011-03-07
36165SUPPL2011-03-04
26841SUPPL2010-10-13
14448SUPPL2010-10-11
26840SUPPL2009-05-01
14447SUPPL2009-04-28
44100ORIG2008-02-01
4396SUPPL2006-05-05
26839SUPPL2005-02-23
14446SUPPL2005-02-23
4395SUPPL2004-06-10
41967SUPPL2004-05-06
21464ORIG2004-05-06
26838SUPPL2002-01-30