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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021453
Company: BRISTOL MYERS SQUIBB

Products on NDA 021453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZERIT XR	STAVUDINE	37.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ZERIT XR	STAVUDINE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ZERIT XR	STAVUDINE	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ZERIT XR	STAVUDINE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21453ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021453_s000_ZeritTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21453s004ltr.pdf
06/04/2004	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21453slr003ltr.pdf

Labels for NDA 021453

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf
06/04/2004	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf
12/31/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf

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