FDA.reportPublic FDA data

Application 209825

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-248Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-248Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-248Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-249Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-249Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-249Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-250Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-250Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
68083-250Doxorubicin HydrochlorideDoxorubicin HydrochlorideGland Pharma LimitedANDACurrent
70860-208Doxorubicin Hydrochloridedoxorubicin hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent