Product Details for NDA 020154
VIDEX (DIDANOSINE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 002
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX (DIDANOSINE)
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 002
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 003
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX (DIDANOSINE)
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 003
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 004
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX (DIDANOSINE)
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 004
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 005
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX (DIDANOSINE)
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 005
Approval Date: Oct 9, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 006
Approval Date: Oct 28, 1999
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VIDEX
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020154
Product Number: 006
Approval Date: Oct 28, 1999
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information