Drugs@FDA: FDA-Approved Drugs
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 |