Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020412
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZERIT STAVUDINE 5MG CAPSULE;ORAL Discontinued None No No
ZERIT STAVUDINE 15MG CAPSULE;ORAL Prescription AB Yes No
ZERIT STAVUDINE 20MG CAPSULE;ORAL Prescription AB Yes No
ZERIT STAVUDINE 30MG CAPSULE;ORAL Prescription AB Yes No
ZERIT STAVUDINE 40MG CAPSULE;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
06/24/1994 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
12/17/2018 SUPPL-41 Labeling-Package Insert, Labeling-Medication Guide 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-40 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
07/14/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/18/2011 SUPPL-38 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-37 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-36 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-34 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-33 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-32 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-30 Labeling 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-29 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-27 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-24 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020412s024lbl.pdf
06/04/2004 SUPPL-23 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-18 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-17 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-16 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-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20412s15lbl.pdf
04/17/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/2000 SUPPL-13 Labeling

Label is not available on this site.

06/10/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/16/1998 SUPPL-11 Labeling

Label is not available on this site.

07/01/1999 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

08/19/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/04/1998 SUPPL-5 Labeling

Label is not available on this site.

09/06/1996 SUPPL-4 Efficacy-New Patient Population

Label is not available on this site.

02/09/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1995 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

08/02/1994 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
12/17/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf
12/17/2018 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf
12/19/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf
12/19/2017 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf
11/18/2011 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf
12/10/2010 SUPPL-36 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf
12/10/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf
07/08/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf
02/13/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf
12/11/2008 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf
04/14/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf
04/14/2008 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf
12/20/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020412s024lbl.pdf
06/04/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf
03/29/2002 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf
10/16/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20412s15lbl.pdf

ZERIT

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 15MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 20MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 30MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 40MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

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