Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 020168
Company: GENENTECH

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

Products on BLA 20168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUTROPIN	SOMATROPIN	5MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
NUTROPIN	SOMATROPIN	10MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for BLA 020168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf