Product Details
WHO Product ID
ANDA 208355 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet 50mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
FPP Manufacturing Site(s)
APL Healthcare Limited
Unit-IV, Plot No 16, APIIC M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District
Andhra Pradesh
524421
India
Aurobindo Pharma Ltd
Unit VII, SEZ, APIIC Plot No SI, Survey No 411, 425, 434, 435 and 458, Green Industrial Park, Village Polepally, Mandal Jedcherla, District Mahaboobnagar
Andhra Pradesh
India