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

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
07/08/2022	SUPPL-6	Supplement		Label is not available on this site.

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