FDA.reportPublic FDA data

Application 077795

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0097OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals ANDACurrent
0054-0097OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0097OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0097OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0097OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0098OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0098OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0098OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0098OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals ANDACurrent
0054-0098OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0099OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0099OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals ANDACurrent
0054-0099OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0099OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
0054-0099OxcarbazepineOxcarbazepineWest-Ward Pharmaceticals Corp.ANDACurrent
50090-2573OxcarbazepineOxcarbazepineA-S Medication SolutionsANDACurrent
55154-4959OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
70518-0111OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24166ORIG2007-10-23
39541ORIG2007-10-10
9084ORIG2007-10-10