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WHO Reference Number | International nonproprietary name (INN) | Therapeutic Area | Applicant | Dosage form & strength | Date of prequalification |
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ANDA 0091611a USFDA 2 | Atazanavir (sulfate) | HIV/AIDS | Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India | Capsules, hard 150mg | |
ANDA 0091611b USFDA 2 | Atazanavir (sulfate) | HIV/AIDS | Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India | Capsules, hard 300mg | |
ANDA 077267 USFDA 1 | Zidovudine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablet 300mg | |
ANDA 077268 USFDA 1 | Zidovudine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Solution, Oral 10mg/ml | |
ANDA 077275b USFDA 2 | Didanosine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablets, Chewable 100mg | |
ANDA 077275c USFDA 2 | Didanosine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablets, Chewable 150mg | |
ANDA 077464a USFDA 2 | Lamivudine | HIV/AIDS | Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India | Tablet 150mg | |
ANDA 077464b USFDA 2 | Lamivudine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablet 300mg | |
ANDA 077521 USFDA 2 | Nevirapine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablet 200mg | |
ANDA 077558 USFDA 2 | Lamivudine/Zidovudine | HIV/AIDS | Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India | Tablet 150mg/300mg |