FDA.reportPublic FDA data

Application 200275

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATENORETHINDRONE ACETATETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-650Norethindrone AcetateNorethindroneAvKARE, Inc.ANDACurrent
42291-650Norethindrone AcetateNorethindroneAvKAREANDACurrent
50268-602Norethindrone AcetateNorethindroneAvPAKANDACurrent
65162-475Norethindrone AcetateNorethindroneAmneal Pharmaceuticals LLCANDACurrent
65162-475Norethindrone AcetateNorethindroneAmneal Pharmaceuticals LLCANDACurrent
65162-475Norethindrone AcetateNorethindroneAmneal Pharmaceuticals LLCANDACurrent
65162-475Norethindrone AcetateNorethindroneAmneal Pharmaceuticals LLCANDACurrent