FDA.reportPublic FDA data

Application 010596

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
007CELONTINMETHSUXIMIDECAPSULE;ORAL150MGYesNo
008CELONTINMETHSUXIMIDECAPSULE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0525CelontinmethsuximideParke-Davis Div of Pfizer IncNDACurrent
24822-525CelontinMETHSUXIMIDEFarmeaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11908SUPPL2011-06-17
23091ORIG2010-10-13
11907SUPPL2010-10-13
10753SUPPL2010-10-11
11906SUPPL2009-04-29
33023SUPPL2009-04-28
226SUPPL2002-04-17
225SUPPL2001-04-09
224SUPPL2001-04-09