Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020154
Company: BRISTOL MYERS SQUIBB
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| VIDEX | DIDANOSINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| VIDEX | DIDANOSINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| VIDEX | DIDANOSINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| VIDEX | DIDANOSINE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| VIDEX | DIDANOSINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |