FDA.reportPublic FDA data

Application 022488

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYRICAPREGABALINSOLUTION;ORAL20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1020LyricaPREGABALINParke-Davis Div of Pfizer IncNDACurrent
59762-1576PregabalinPregabalinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1576PregabalinPregabalinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1576PregabalinPregabalinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82109SUPPL 2025-05-01
82064SUPPL 2025-04-29
82063SUPPL 2025-04-29
76791SUPPL 2024-01-08
76829SUPPL 2024-01-05
62514SUPPL2020-04-09
62449SUPPL2020-04-06
58856SUPPL2019-05-24
58854SUPPL2019-05-24
58851SUPPL2019-05-24
54040SUPPL2018-05-08
54025SUPPL2018-05-04
54024SUPPL2018-05-04
46529SUPPL2016-12-23
46516SUPPL2016-12-22
17643SUPPL2016-03-15
29779SUPPL2016-03-11
29778SUPPL2013-12-26
17642SUPPL2013-12-24
38762SUPPL2013-03-15
7459SUPPL2013-03-01
7458SUPPL2012-04-18
38760SUPPL2011-08-30
29776SUPPL2011-08-26
38761SUPPL2011-07-07
29777SUPPL2011-06-29
38759SUPPL2011-04-29
29775SUPPL2011-04-29
29774SUPPL2011-04-29
17641SUPPL2011-04-29
17640SUPPL2011-04-29
7457SUPPL2011-04-29
24321ORIG2010-06-22
22034ORIG2010-06-22
17639ORIG2010-01-08
29773ORIG2010-01-06
66982SUPPL1900-01-01
66981SUPPL1900-01-01
66980SUPPL1900-01-01
66979SUPPL1900-01-01
66978SUPPL1900-01-01
66977SUPPL1900-01-01