Product Details for NDA 020972
SUSTIVA (EFAVIRENZ)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Active Ingredient: EFAVIRENZ
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020972
Product Number: 001
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
SUSTIVA (EFAVIRENZ)
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020972
Product Number: 001
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
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100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: EFAVIRENZ
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020972
Product Number: 002
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
SUSTIVA (EFAVIRENZ)
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020972
Product Number: 002
Approval Date: Sep 17, 1998
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: EFAVIRENZ
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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: N020972
Product Number: 003
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; 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: N020972
Product Number: 003
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information