FDA.reportPublic FDA data

Application 208657

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62202ORIG2020-03-19