FDA.reportPublic FDA data

Application 200980

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONENORETHINDRONETABLET;ORAL-280.35MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7272NorethindroneNorethindroneMylan Pharmaceuticals Inc.ANDACurrent
0378-7272NorethindroneNorethindroneMylan Pharmaceuticals Inc.ANDACurrent
0378-7272NorethindroneNorethindroneMylan Pharmaceuticals Inc.ANDACurrent
0378-7272NorethindroneNorethindroneMylan Pharmaceuticals Inc.ANDACurrent
50102-100LYZAnorethindroneAfaxys Pharma LLCANDACurrent
50102-100LYZAnorethindroneAfaxys Pharma LLCANDACurrent
50102-100LYZAnorethindroneAfaxys Pharma LLCANDACurrent
53002-1687LYZAnorethindroneRPK Pharmaceuticals, Inc.ANDACurrent
53002-1687LYZAnorethindroneRPK Pharmaceuticals, Inc.ANDACurrent
70518-3113NorethindroneNorethindroneREMEDYREPACK INC.ANDACurrent