Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761136
Company: CELGENE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REBLOZYL LUSPATERCEPT-AAMT 25MG/VIAL POWDER;SUBCUTANEOUS Prescription None No No
REBLOZYL LUSPATERCEPT-AAMT 75MG/VIAL POWDER;SUBCUTANEOUS Prescription None 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
04/03/2020 ORIG-2 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761136Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761136Orig2s000TOC.cfm
11/08/2019 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761136Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761136Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2020 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf
11/08/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf

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