FDA.reportPublic FDA data

Application 208888

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION20MG/VIALNoNo
002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1218Doxorubicin HydrochlorideDoxorubicinAmneal Pharmaceuticals LLCANDACurrent
70121-1218Doxorubicin HydrochlorideDoxorubicinAmneal Pharmaceuticals LLCANDACurrent
70121-1218Doxorubicin HydrochlorideDoxorubicinAmneal Pharmaceuticals LLCANDACurrent
70121-1218Doxorubicin HydrochlorideDoxorubicinAmneal Pharmaceuticals LLCANDACurrent
70121-1218Doxorubicin HydrochlorideDoxorubicinAmneal BiosciencesANDACurrent
70121-1219Doxorubicin HydrochlorideDoxorubicin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1219Doxorubicin HydrochlorideDoxorubicin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1219Doxorubicin HydrochlorideDoxorubicin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1219Doxorubicin HydrochlorideDoxorubicin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1219Doxorubicin HydrochlorideDoxorubicin HydrochlorideAmneal BiosciencesANDACurrent