Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021088
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIADUR LEUPROLIDE ACETATE EQ 65MG BASE IMPLANT;IMPLANTATION 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
03/03/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21088ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/02-1088_Vidaur.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2011 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021088s025ltr.pdf
09/15/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s022ltr.pdf
10/21/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21088slr015ltr.pdf
05/23/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/17/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/13/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s007ltr.pdf
07/05/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/24/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/16/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/28/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/14/2011 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf
09/15/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s022lbl.pdf
09/08/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf
03/03/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21088lbl.pdf

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