Drugs@FDA: FDA Approved Drug Products

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

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/25/2003 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21320ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-320_Plenaxis.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2005 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021320s002ltr.pdf

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

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