Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020412
Company: BRISTOL

• Medication Guide

Products on NDA 20412

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ZERIT	STAVUDINE	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ZERIT	STAVUDINE	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ZERIT	STAVUDINE	30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ZERIT	STAVUDINE	40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 020412

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2018	SUPPL-41	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf
12/17/2018	SUPPL-41	Labeling-Package Insert	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	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf
12/10/2010	SUPPL-36	REMS-Proposal	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