Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 021538
Company: EMERGENT

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

• Summary Review

Products on BLA 21538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACCRETROPIN	SOMATROPIN	5MG/ML (5MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for BLA 021538

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021538s002lbl.pdf
01/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf