Details for New Drug Application (NDA): 021183

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NDA 021183 describes VIDEX EC, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the VIDEX EC profile page.

The generic ingredient in VIDEX EC is didanosine. There are eight drug master file entries for this compound. Additional details are available on the didanosine profile page.

Summary for 021183

Tradename:	VIDEX EC
Applicant:	Bristol Myers Squibb
Ingredient:	didanosine
Patents:	0

Medical Subject Heading (MeSH) Categories for 021183

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021183

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-004	Oct 31, 2000	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-001	Oct 31, 2000	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-003	Oct 31, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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