Details for New Drug Application (NDA): 020412

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NDA 020412 describes ZERIT, which is a drug marketed by Bristol and Bristol Myers Squibb and is included in three NDAs. Additional details are available on the ZERIT profile page.

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

Summary for 020412

Tradename:	ZERIT
Applicant:	Bristol
Ingredient:	stavudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 020412

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jun 24, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 24, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 24, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020412

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994	4,978,655*PED	⤷ Subscribe
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-005	Jun 24, 1994	4,978,655*PED	⤷ Subscribe
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994	4,978,655*PED	⤷ Subscribe
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-002	Jun 24, 1994	4,978,655*PED	⤷ Subscribe
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-003	Jun 24, 1994	4,978,655*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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