FDA.reportPublic FDA data

Application 211226

Type
NDA
Sponsor
ACROTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KHAPZORYLEVOLEUCOVORINPOWDER;INTRAVENOUS175MG/VIALYesYes
002KHAPZORYLEVOLEUCOVORINPOWDER;INTRAVENOUS300MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68152-112KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-112KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-112KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-114KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-114KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-114KHAPZORYlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
72893-004KHAPZORYlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-004KHAPZORYlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-006KHAPZORYlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-006KHAPZORYlevoleucovorinAcrotech Biopharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62039SUPPL2020-03-05
62021SUPPL2020-03-04
57034ORIG2018-12-26
56081ORIG2018-10-23
56047ORIG2018-10-22