FDA.reportPublic FDA data

Application 077562

Type
ANDA
Sponsor
SANDOZ INC

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
0781-2164ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2164ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2164ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2164ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2164ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2166ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2166ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2166ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2166ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2166ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2167ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2167ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2167ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2167ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2167ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2168ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2168ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2168ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2168ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
0781-2168ziprasidone hydrochlorideziprasidone hydrochlorideSandoz IncANDACurrent
50090-3823ziprasidone hydrochlorideziprasidone hydrochlorideA-S Medication SolutionsANDACurrent
50090-3823ziprasidone hydrochlorideziprasidone hydrochlorideA-S Medication SolutionsANDACurrent
63187-168ziprasidone hydrochlorideziprasidone hydrochlorideProficient Rx LPANDACurrent
63187-168ziprasidone hydrochlorideziprasidone hydrochlorideProficient Rx LPANDACurrent
64725-2164ziprasidone hydrochlorideziprasidone hydrochlorideTYA PharmaceuticalsANDACurrent
64725-2168ziprasidone hydrochlorideziprasidone hydrochlorideTYA PharmaceuticalsANDACurrent
70518-1586ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1586ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1586ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1586ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1586ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2366ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2366ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2366ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2367ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2367ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2367ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0263ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent
71335-0263ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent
71335-0263ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent
71335-0263ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9061ORIG2011-04-21
44356ORIG2008-11-13