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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021088
Company: ORTHO MCNEIL JANSSEN

Other Important Information from FDA

Products on NDA 021088

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021088

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.html

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.

Labels for NDA 021088

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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