FDA.reportPublic FDA data

Application 074434

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPTOPRILCAPTOPRILTABLET;ORAL12.5MGNoNo
002CAPTOPRILCAPTOPRILTABLET;ORAL25MGNoNo
003CAPTOPRILCAPTOPRILTABLET;ORAL50MGNoNo
004CAPTOPRILCAPTOPRILTABLET;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3007CaptoprilcaptoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-3012CaptoprilcaptoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-3017CaptoprilcaptoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-3022CaptoprilcaptoprilMylan Pharmaceuticals Inc.ANDACurrent
43063-146CaptoprilcaptoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
51079-863CaptoprilcaptoprilMylan Institutional Inc.ANDACurrent
51079-864CaptoprilcaptoprilMylan Institutional Inc.ANDACurrent
70518-0406CaptoprilcaptoprilREMEDYREPACK INC.ANDACurrent