Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020156
Company: BRISTOL
Company: BRISTOL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIDEX | DIDANOSINE | 10MG/ML | FOR SOLUTION;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/09/1991 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/17/2018 | SUPPL-54 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020156Orig1s054ltr.pdf | |
| 01/25/2018 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020156Orig1s053ltr.pdf | |
| 08/08/2014 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020156Orig1s051ltr.pdf | |
| 11/18/2011 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s048ltr.pdf | |
| 05/10/2011 | SUPPL-47 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024ltr.pdf |
| 01/25/2010 | SUPPL-46 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf | |
| 06/11/2009 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020156s044ltr.pdf | |
| 11/29/2006 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf | |
| 08/18/2006 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020156_S039_VIDEX.pdf | |
| 01/21/2004 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf | |
| 03/04/2003 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf | |
| 09/25/2002 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm | |
| 09/25/2002 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm | |
| 04/01/2002 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf | |
| 11/16/2001 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s28lbl.pdf | |
| 09/10/2001 | SUPPL-27 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf | |
| 07/27/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/24/2000 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm |
| 07/24/2000 | SUPPL-24 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm |
| 07/03/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-22 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm | |
| 07/01/1999 | SUPPL-21 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm |
| 03/05/1998 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/17/1996 | SUPPL-16 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020156_S016_VIDEX.pdf |
| 03/13/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/10/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-7 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020156_S007_VIDEX.pdf |
| 08/21/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/10/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/25/1992 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/17/2018 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf | |
| 12/17/2018 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf | |
| 01/25/2018 | SUPPL-53 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf | |
| 01/25/2018 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf | |
| 08/08/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf | |
| 08/08/2014 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf | |
| 11/18/2011 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048lbl.pdf | |
| 01/25/2010 | SUPPL-46 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf | |
| 06/11/2009 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf | |
| 11/29/2006 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf | |
| 08/18/2006 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf | |
| 01/21/2004 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf | |
| 03/04/2003 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf | |
| 09/25/2002 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf | |
| 09/25/2002 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf | |
| 04/01/2002 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf | |
| 11/16/2001 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s28lbl.pdf | |
| 09/10/2001 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf | |
| 10/28/1999 | SUPPL-22 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF |