Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020972

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SUSTIVA (EFAVIRENZ)
50MG Marketing Status: Prescription

Active Ingredient: EFAVIRENZ
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020972
Product Number: 001
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SUSTIVA (EFAVIRENZ)
200MG Marketing Status: Prescription

Active Ingredient: EFAVIRENZ
Proprietary Name: SUSTIVA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020972
Product Number: 003
Approval Date: Sep 17, 1998
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SUSTIVA (EFAVIRENZ)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

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