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Last Updated: July 3, 2020

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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. It is available from one supplier. 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. Two suppliers are listed 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021183
Medical Subject Heading (MeSH) Categories for 021183
Suppliers and Packaging for NDA: 021183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIDEX EC didanosine CAPSULE, DELAYED REL PELLETS;ORAL 021183 NDA Bristol-Myers Squibb Company 0087-6671 0087-6671-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6671-17)
VIDEX EC didanosine CAPSULE, DELAYED REL PELLETS;ORAL 021183 NDA Bristol-Myers Squibb Company 0087-6672 0087-6672-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6672-17)
Paragraph IV (Patent) Challenges for 021183
Tradename Dosage Ingredient NDA Submissiondate
VIDEX EC CAPSULE, DELAYED REL PELLETS;ORAL didanosine 021183 2004-06-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength125MG
Approval Date:Oct 31, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength200MG
Approval Date:Oct 31, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Oct 31, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021183

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

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