Medicines/finished pharmaceutical products

Reference Number: 
ANDA 078064b USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Efavirenz
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Capsules, hard 200mg
Packaging: 
Blister:10x1; Bottle HDPE: 30x1, 90x1
Applicant: 
Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India
FPP Manufacturing Site: 

Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India