Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020162
Company: FERRING

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

Products on BLA 020162

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTHREL	CORTICORELIN OVINE TRIFLUTATE	EQ 0.1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020162

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/1996	ORIG-1	Approval		N/A; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2015	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020162Orig1s010ltr.pdf
01/31/2014	SUPPL-9	Supplement		Label is not available on this site.
07/16/2002	SUPPL-3	Supplement		Label is not available on this site.
04/24/1997	SUPPL-2	Supplement		Label is not available on this site.
04/04/1997	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 020162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf