Application 204707

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-280PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-280PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-280PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-280PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-281PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-281PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-281PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-281PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-282PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-282PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-282PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-282PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-283PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-283PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-283PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-283PaliperidonePaliperidoneAmneal Pharmaceuticals LLCANDACurrent
70518-2509PaliperidonePaliperidoneREMEDYREPACK INC.ANDACurrent