FDA.reportPublic FDA data

Application 213317

Type
ANDA
Sponsor
CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMMILYETHINYL ESTRADIOL; NORETHINDRONE ACETATECAPSULE;ORAL0.02MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-155norethindrone acetate and ethinyl estradiol, and ferrous fumaratenorethindrone acetate and ethinyl estradiol, and ferrous fumarateNorthstar Rx LLCANDACurrent
70700-152Gemmilynorethindrone acetate and ethinyl estradiol, and ferrous fumarateXiromed, LLCANDACurrent
70700-152Gemmilynorethindrone acetate and ethinyl estradiol, and ferrous fumarateXiromed, LLCANDACurrent
70700-152Gemmilynorethindrone acetate and ethinyl estradiol, and ferrous fumarateXiromed, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65855ORIG2021-01-07