Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020155
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIDEX DIDANOSINE 100MG/PACKET FOR SOLUTION;ORAL Discontinued None No No
VIDEX DIDANOSINE 167MG/PACKET FOR SOLUTION;ORAL Discontinued None No No
VIDEX DIDANOSINE 250MG/PACKET FOR SOLUTION;ORAL Discontinued None No No
VIDEX DIDANOSINE 375MG/PACKET FOR SOLUTION;ORAL 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
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
11/29/2006 SUPPL-39 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-38 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/2006/020155_S038_VIDEX.pdf
01/21/2004 SUPPL-34 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-32 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-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
09/25/2002 SUPPL-30 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-28 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-27 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s27lbl.pdf
09/10/2001 SUPPL-26 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s26lbl.pdf
07/27/2001 SUPPL-25 Labeling

Label is not available on this site.

07/24/2000 SUPPL-24 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-23 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-22 Labeling

Label is not available on this site.

10/28/1999 SUPPL-21 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-20 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
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/96/020155_S007_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/pre96/020155_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
11/29/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf
08/18/2006 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf
01/21/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf
03/04/2003 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf
09/25/2002 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
09/25/2002 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
04/01/2002 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf
11/16/2001 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s27lbl.pdf
09/10/2001 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s26lbl.pdf
10/28/1999 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF

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