Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020154
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIDEX DIDANOSINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
VIDEX DIDANOSINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
VIDEX DIDANOSINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
VIDEX DIDANOSINE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
VIDEX DIDANOSINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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 1 - New Molecular Entity 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-50 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
01/21/2004 SUPPL-44 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-42 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-41 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-40 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
08/23/2002 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2002 SUPPL-37 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-36 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s36lbl.pdf
09/10/2001 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s35lbl.pdf
07/27/2001 SUPPL-34 Labeling

Label is not available on this site.

07/24/2000 SUPPL-33 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-32 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-31 Labeling

Label is not available on this site.

10/28/1999 SUPPL-30 Manufacturing (CMC)-Formulation 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
10/28/1999 SUPPL-29 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-28 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
11/25/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1998 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1998 SUPPL-23 Labeling

Label is not available on this site.

07/31/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/26/1996 SUPPL-21 Labeling

Label is not available on this site.

07/17/1996 SUPPL-20 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020154_S020_VIDEX.pdf
03/13/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1995 SUPPL-17 Labeling

Label is not available on this site.

06/26/1996 SUPPL-16 Labeling

Label is not available on this site.

08/21/1995 SUPPL-15 Labeling

Label is not available on this site.

08/21/1995 SUPPL-14 Labeling

Label is not available on this site.

02/10/1994 SUPPL-13 Labeling

Label is not available on this site.

08/21/1995 SUPPL-12 Labeling

Label is not available on this site.

02/27/1996 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/13/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1994 SUPPL-9 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S009_VIDEX.pdf
08/21/1995 SUPPL-8 Labeling

Label is not available on this site.

02/10/1994 SUPPL-7 Labeling

Label is not available on this site.

09/25/1992 SUPPL-6 Efficacy-New Dosing Regimen

Label is not available on this site.

02/04/1993 SUPPL-4 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S004_VIDEX.pdf
04/01/1992 SUPPL-1 Manufacturing (CMC)-Control

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-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf
01/21/2004 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf
03/04/2003 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf
09/25/2002 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
09/25/2002 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
04/01/2002 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf
11/16/2001 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s36lbl.pdf
09/10/2001 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s35lbl.pdf
10/28/1999 SUPPL-30 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF
10/28/1999 SUPPL-29 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English