Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209422
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARFILZOMIB CARFILZOMIB 60MG/VIAL POWDER;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/09/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CARFILZOMIB

POWDER;INTRAVENOUS; 60MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARFILZOMIB CARFILZOMIB 60MG/VIAL POWDER;INTRAVENOUS Prescription No AP 209425 APOTEX
CARFILZOMIB CARFILZOMIB 60MG/VIAL POWDER;INTRAVENOUS Prescription No AP 209422 DR REDDYS
KYPROLIS CARFILZOMIB 60MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202714 ONYX THERAP

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