Drugs@FDA: FDA-Approved Drugs

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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 021538

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2008	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021538s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538_accretropin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2016	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021538s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021538Orig1s002ltr.pdf

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