FDA.reportPublic FDA data

Application 201993

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 5MG BASENoNo
002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1403Rizatriptan Benzoaterizatriptan benzoateMylan Pharmaceuticals Inc.ANDACurrent
0378-1403Rizatriptan Benzoaterizatriptan benzoateMylan Pharmaceuticals Inc.ANDACurrent
0378-1404Rizatriptan Benzoaterizatriptan benzoateMylan Pharmaceuticals Inc.ANDACurrent
0378-1404Rizatriptan Benzoaterizatriptan benzoateMylan Pharmaceuticals Inc.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent
70518-0509Rizatriptan Benzoaterizatriptan benzoateREMEDYREPACK INC.ANDACurrent