Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020156
Company: BRISTOL

• Medication Guide

• Other Important Information from FDA

Products on NDA 20156

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIDEX	DIDANOSINE	10MG/ML	FOR SOLUTION;ORAL	Discontinued	None	Yes	No

Labels for NDA 020156

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2018	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf
12/17/2018	SUPPL-54	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf
01/25/2018	SUPPL-53	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf
01/25/2018	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf
08/08/2014	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf
08/08/2014	SUPPL-51	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf
11/18/2011	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048lbl.pdf
01/25/2010	SUPPL-46	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf
06/11/2009	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf
11/29/2006	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf
08/18/2006	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf
01/21/2004	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf
03/04/2003	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf
09/25/2002	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
09/25/2002	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf
04/01/2002	SUPPL-29	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf
11/16/2001	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s28lbl.pdf
09/10/2001	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf
10/28/1999	SUPPL-22	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF