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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 021453

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NDA 021453 describes ZERIT XR, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the ZERIT XR profile page.

The generic ingredient in ZERIT XR is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for 021453

Tradename:	ZERIT XR
Applicant:	Bristol Myers Squibb
Ingredient:	stavudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 021453

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	37.5MG
Approval Date:	Dec 31, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Dec 31, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	75MG
Approval Date:	Dec 31, 2002	TE:		RLD:	No

Expired US Patents for NDA 021453

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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