Application 212080

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTEPREDNOL ETABONATELOTEPREDNOL ETABONATEGEL;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-830Loteprednol EtabonateLoteprednol EtabonateAkornANDACurrent
17478-830Loteprednol EtabonateLoteprednol EtabonateAkornANDACurrent
17478-830Loteprednol EtabonateLoteprednol EtabonateAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66718ORIG2021-03-10