FDA.reportPublic FDA data

Application 203263

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)NoYes
002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
68001-492Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-492Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-493Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-493Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53718ORIG2018-04-18
32403ORIG2013-02-05
40283ORIG2013-02-04