FDA.reportPublic FDA data

Application 012380

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZARONTINETHOSUXIMIDECAPSULE;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0237ZarontinEthosuximideParke-Davis Div of Pfizer IncNDACurrent
0071-0237ZarontinEthosuximideParke-Davis Div of Pfizer IncNDACurrent
59762-2250EthosuximideEthosuximideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2250EthosuximideEthosuximideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2250EthosuximideEthosuximideGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69167SUPPL2021-10-29
69161SUPPL2021-10-29
33085SUPPL2016-05-20
330SUPPL2016-05-20
329SUPPL2012-05-09
43585SUPPL2012-05-07
10808SUPPL2012-05-07
328SUPPL2011-06-17
10807SUPPL2010-09-20
327SUPPL2010-09-20
12012SUPPL2009-04-29
33084SUPPL2009-04-28
326SUPPL2006-09-18
12011SUPPL2002-04-19
12010SUPPL2001-04-09
12009SUPPL2001-04-09
325SUPPL2001-04-09