Product Details for NDA 021183
VIDEX EC (DIDANOSINE)
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021183
Product Number: 001
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX EC (DIDANOSINE)
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021183
Product Number: 001
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
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200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; 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Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021183
Product Number: 002
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX EC (DIDANOSINE)
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; 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: N021183
Product Number: 002
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 250MG **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: N021183
Product Number: 003
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
VIDEX EC (DIDANOSINE)
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 250MG **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: N021183
Product Number: 003
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIDANOSINE
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 400MG **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: N021183
Product Number: 004
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VIDEX EC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 400MG **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: N021183
Product Number: 004
Approval Date: Oct 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information