FDA.reportPublic FDA data

Application 203802

Type
ANDA
Sponsor
MYLAN

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
0378-3978PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3978PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3978PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3979PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3979PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3979PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3980PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3980PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3980PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3981PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3981PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-3981PaliperidonepaliperidoneMylan Pharmaceuticals Inc.ANDACurrent
42292-026PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-026PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-026PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-026PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-026PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-027PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-027PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-027PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-027PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-027PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-055PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-055PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
42292-055PaliperidonepaliperidoneMylan Institutional Inc.ANDACurrent
72819-157PaliperidonepaliperidoneArchis Pharma LLCANDACurrent
72819-158PaliperidonepaliperidoneArchis Pharma LLCANDACurrent
72819-159PaliperidonepaliperidoneArchis Pharma LLCANDACurrent
72819-160PaliperidonepaliperidoneArchis Pharma LLCANDACurrent