Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021183
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIDEX EC DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
VIDEX EC DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
VIDEX EC DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
VIDEX EC DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB 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
10/31/2000 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21183lbl1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/2018 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021183Orig1s029ltr.pdf
01/25/2018 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021183Orig1s028ltr.pdf
11/18/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021183s025ltr.pdf
05/10/2011 SUPPL-24 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-23 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf
06/10/2009 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021183s022ltr.pdf
09/29/2008 SUPPL-20 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021183s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021183s020ltr.pdf
11/29/2006 SUPPL-16 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-15 Labeling Label (PDF)
Letter (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
01/21/2004 SUPPL-10 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-7 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
10/16/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf
10/16/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf
08/05/2002 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr004ltr.pdf
04/01/2002 SUPPL-3 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
01/29/2002 SUPPL-2 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-183s002_Videx.cfm
01/28/2002 SUPPL-1 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021183_S001_VIDEX_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/17/2018 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s029lbl.pdf
12/17/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s029lbl.pdf
01/25/2018 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s028lbl.pdf
01/25/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s028lbl.pdf
11/18/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025lbl.pdf
01/25/2010 SUPPL-23 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023lbl.pdf
06/10/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf
09/29/2008 SUPPL-20 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021183s020lbl.pdf
11/29/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf
08/18/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf
01/21/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf
03/04/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf
10/16/2002 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf
10/16/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf
08/05/2002 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf
04/01/2002 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf
10/31/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21183lbl1.pdf

VIDEX EC

CAPSULE, DELAYED REL PELLETS;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

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