Medicines/finished pharmaceutical products

Reference Number: 
NDA 208255 USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 400mg/300mg/300mg
Packaging: 
Bottle, HDPE 30x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India