FDA.reportPublic FDA data

Application 090348

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo
003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASENoNo
004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-991Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt LimitedANDACurrent
55648-992Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt LimitedANDACurrent
55648-993Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt LimitedANDACurrent
55648-994Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt LimitedANDACurrent
64679-991Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-991Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-992Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-992Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-993Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-993Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-994Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64679-994Ziprasidone hydrochlorideZiprasidone hydrochlorideWockhardt USA LLC.ANDACurrent
64725-0993Ziprasidone hydrochlorideZiprasidone hydrochlorideTYA PharmaceuticalsANDACurrent
64725-0994Ziprasidone hydrochlorideZiprasidone hydrochlorideTYA PharmaceuticalsANDACurrent