FDA.reportPublic FDA data

Application 080258

Type
ANDA
Sponsor
PARKE-DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZARONTINETHOSUXIMIDESYRUP;ORAL250MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
0071-2418ZarontinEthosuximideParke-Davis Div of Pfizer IncANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent
59762-2350EthosuximideEthosuximideGreenstone LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39570SUPPL2014-01-22
39569SUPPL2014-01-22
39568SUPPL2009-10-19