Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078064

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EFAVIRENZ (EFAVIRENZ)
50MG
Marketing Status: Prescription

Active Ingredient: EFAVIRENZ
Proprietary Name: EFAVIRENZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078064
Product Number: 001
Approval Date: Dec 15, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

EFAVIRENZ (EFAVIRENZ)
100MG
Marketing Status: Prescription

Active Ingredient: EFAVIRENZ
Proprietary Name: EFAVIRENZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078064
Product Number: 002
Approval Date: Dec 15, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

EFAVIRENZ (EFAVIRENZ)
200MG
Marketing Status: Prescription

Active Ingredient: EFAVIRENZ
Proprietary Name: EFAVIRENZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A078064
Product Number: 003
Approval Date: Dec 15, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information