Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761147
Company: ACCORD BIOPHARMA INC.

Products on BLA 761147

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENNUMO	PEGFILGRASTIM-PCCG	6MG/0.6ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2026	ORIG-1	Approval		N/A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761147Orig1s000ltr.pdf