Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020413
Company: BRISTOL-MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZERIT STAVUDINE 1MG/ML FOR SOLUTION;ORAL Prescription None 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
09/06/1996 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-33 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020412Orig1s041, 020413Orig1s033ltr.pdf
12/19/2017 SUPPL-32 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020412Orig1s040, 020413Orig1s032ltr.pdf
11/18/2011 SUPPL-30 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s038,020413s030ltr.pdf
05/11/2011 SUPPL-29 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s037,020413s029ltr.pdf
12/10/2010 SUPPL-28 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028ltr.pdf
07/08/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s034,020413s026ltr.pdf
02/13/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s033,020413s025ltr.pdf
12/11/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032, 020413s023ltr.pdf
04/14/2008 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030, 020413s021ltr.pdf
04/14/2008 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029, 020413s020ltr.pdf
06/20/2007 SUPPL-18 Labeling Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf
12/20/2005 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020413s015lbl.pdf
06/04/2004 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20412slr023,20413slr014ltr.pdf
02/20/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf
02/20/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf
03/29/2002 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s16ltr.pdf
10/16/2001 SUPPL-6 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20413s6lbl.pdf
09/27/2000 SUPPL-5 Labeling

Label is not available on this site.

09/16/1998 SUPPL-4 Labeling

Label is not available on this site.

07/01/1999 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

08/19/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1998 SUPPL-1 Labeling

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-33 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf
12/17/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf
12/19/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf
12/19/2017 SUPPL-32 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf
11/18/2011 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf
12/10/2010 SUPPL-28 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf
12/10/2010 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf
07/08/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf
02/13/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf
12/11/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf
04/14/2008 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf
04/14/2008 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf
04/14/2008 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf
12/20/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020413s015lbl.pdf
06/04/2004 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf
03/29/2002 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf
10/16/2001 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20413s6lbl.pdf

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