Drugs@FDA: FDA-Approved Drugs
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 |