FDA.reportPublic FDA data

Application 207155

Type
NDA
Sponsor
ACROTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVOMELAMELPHALAN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 50MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68152-109EVOMELAMelphalanSpectrum Pharmaceuticals, Inc.NDACurrent
68152-109EVOMELAMelphalanSpectrum Pharmaceuticals, Inc.NDACurrent
68152-109EVOMELAMelphalanSpectrum Pharmaceuticals, Inc.NDACurrent
68152-109EVOMELAMelphalanSpectrum Pharmaceuticals, Inc.NDACurrent
68152-109EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent
69605-001EVOMELAMelphalanCENEXI - BLANDACurrent
72893-001EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent
72893-001EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent
72893-001EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent
72893-001EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent
72893-001EVOMELAMelphalanAcrotech Biopharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70948SUPPL2022-05-03
70820SUPPL2022-04-27
68345SUPPL2021-08-11
68326SUPPL2021-08-10
50934SUPPL2017-12-27
46006ORIG2016-12-02
46005ORIG2016-12-02
19960ORIG2016-03-15
32849ORIG2016-03-14