Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021320
Company: SPECIALITY EUROPEAN

Products on NDA 21320

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLENAXIS	ABARELIX	100MG/VIAL	INJECTABLE;INTRAMUSCULAR	Discontinued	None	No	No

Labels for NDA 021320

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2005	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf
11/25/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf