FDA.reportPublic FDA data

Application 204452

Type
ANDA
Sponsor
INVENTIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL1.5MGNoNo
002PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL3MGNoNo
003PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL6MGNoNo
004PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL9MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-349PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-349PALIPERIDONEPALIPERIDONEAmerigen Pharmaceuticals, Inc.ANDACurrent
43975-349PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-349PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-350PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-350PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-350PALIPERIDONEPALIPERIDONEAmerigen Pharmaceuticals, Inc.ANDACurrent
43975-350PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-351PALIPERIDONEPALIPERIDONEAmerigen Pharmaceuticals, Inc.ANDACurrent
43975-351PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-351PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-351PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-352PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-352PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
43975-352PALIPERIDONEPALIPERIDONEAmerigen Pharmaceuticals, Inc.ANDACurrent
43975-352PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.ANDACurrent
49252-032PALIPERIDONEPALIPERIDONEInventia Healthcare LimitedANDACurrent
49252-033PALIPERIDONEPALIPERIDONEInventia Healthcare LimitedANDACurrent
49252-034PALIPERIDONEPALIPERIDONEInventia Healthcare LimitedANDACurrent
49252-035PALIPERIDONEPALIPERIDONEInventia Healthcare LimitedANDACurrent