FDA.reportPublic FDA data

Application 209501

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYRICA CRPREGABALINTABLET, EXTENDED RELEASE;ORAL82.5MGYesNo
002LYRICA CRPREGABALINTABLET, EXTENDED RELEASE;ORAL165MGYesNo
003LYRICA CRPREGABALINTABLET, EXTENDED RELEASE;ORAL330MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-1026Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1026Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1026Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1026Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1027Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1027Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1027Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1027Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1029Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1029Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1029Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
0071-1029Lyrica CRPREGABALINParke-Davis Div of Pfizer IncNDACurrent
63539-024Lyrica CRPREGABALINU.S. PharmaceuticalsNDACurrent
63539-024Lyrica CRPREGABALINU.S. PharmaceuticalsNDACurrent
63539-024Lyrica CRPREGABALINU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82105SUPPL 2025-05-01
82060SUPPL 2025-04-29
82059SUPPL 2025-04-29
76825SUPPL 2024-04-10
76793SUPPL 2024-01-08
62517SUPPL2020-04-09
62445SUPPL2020-04-06
56106ORIG2018-10-26
50021ORIG2017-10-12
50018ORIG2017-10-12
50017ORIG2017-10-12