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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020637
Company: AZURITY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIADEL CARMUSTINE 7.7MG IMPLANT;INTRACRANIAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/23/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020637Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2018 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020637s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020637s029ltr.pdf
06/01/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
11/20/2014 SUPPL-27 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020637Orig1s027ltr.pdf
08/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020637s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020637Orig1s026ltr.pdf
12/26/2006 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020637s022ltr.pdf
11/07/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
02/25/2003 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020637s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20637se1-016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-637s016_Gliadel.cfm
05/15/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
08/08/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
10/25/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
07/16/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/27/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
10/16/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/12/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
01/22/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
08/22/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
09/15/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
04/04/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
10/08/1996 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
12/05/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020637s029lbl.pdf
08/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020637s026lbl.pdf
02/25/2003 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020637s016lbl.pdf
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