FDA.reportPublic FDA data

Application 065389

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL150MGNoNo
002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61748-113demeclocycline hydrochloridedemeclocycline hydrochlorideVersapharm IncorporatedANDACurrent
61748-113demeclocycline hydrochloridedemeclocycline hydrochlorideVersaPharm Inc - an Akorn CompanyANDACurrent
61748-113demeclocycline hydrochloridedemeclocycline hydrochlorideVersaPharm IncorporatedANDACurrent
61748-115demeclocycline hydrochloridedemeclocycline hydrochlorideVersapharm IncorporatedANDACurrent
61748-115demeclocycline hydrochloridedemeclocycline hydrochlorideVersaPharm Inc - an Akorn CompanyANDACurrent
61748-115demeclocycline hydrochloridedemeclocycline hydrochlorideVersaPharm IncorporatedANDACurrent