FDA.reportPublic FDA data

Application 205363

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL2MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL5MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL10MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL15MGNoNo
005ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL20MGNoNo
006ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-302ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-302ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-302ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-303ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-303ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-303ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-304ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-304ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-304ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-305ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-305ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-305ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-306ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-306ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-306ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-307ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-307ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
43547-307ARIPIPRAZOLEaripiprazoleSolco Healthcare U.S., LLCANDACurrent
70518-2508ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2508ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2508ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2515ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2515ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2669ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2669ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2669ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2827ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2827ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2827ARIPIPRAZOLEaripiprazoleREMEDYREPACK INC.ANDACurrent