FDA.reportPublic FDA data

Application 212226

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POSACONAZOLEPOSACONAZOLETABLET, DELAYED RELEASE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-7711POSACONAZOLEposaconazoleSpecGx LLCANDACurrent
51407-676POSACONAZOLEposaconazoleGolden State Medical Supply, Inc.ANDACurrent