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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. Five suppliers are listed for this compound. Additional details are available on the didanosine profile page.

Summary for NDA: 021183

Tradename:
VIDEX EC
Applicant:
Bristol Myers Squibb
Ingredient:
didanosine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength125MG
Approval Date:Oct 31, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength200MG
Approval Date:Oct 31, 2000TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Oct 31, 2000TE:ABRLD:No

Expired Orange Book 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;ORAL021183-004Oct 31, 20004,861,759*PED► subscribe
Bristol Myers Squibb
VIDEX EC
didanosine
CAPSULE, DELAYED REL PELLETS;ORAL021183-004Oct 31, 20005,254,539*PED► subscribe
Bristol Myers Squibb
VIDEX EC
didanosine
CAPSULE, DELAYED REL PELLETS;ORAL021183-001Oct 31, 20004,861,759*PED► subscribe
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