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Application 205580

Type
NDA
Sponsor
EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BELRAPZOBENDAMUSTINE HYDROCHLORIDESOLUTION;IV (INFUSION)100MG/4ML (25MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42367-520BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-520BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent
42367-521BELRAPZObendamustine hydrochlorideEagle Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77227SUPPL 2024-01-16
77211SUPPL 2024-01-16
71215SUPPL2022-06-06
71207SUPPL2022-06-03
69022SUPPL2021-10-19
69001SUPPL2021-10-15
60756SUPPL2019-10-31
60752SUPPL2019-10-31
58073ORIG2019-03-25
56730SUPPL2018-12-13
54313ORIG2018-05-23
54226ORIG2018-05-23