Medicines/Finished Pharmaceutical Products

E.g., 10/17/2019
E.g., 10/17/2019
Formulation:
Legend:
  • "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
  • [A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
  • (a) means SRA-approved innovator or SRA-approved generic that has been prequalified based on abbreviated assessment
  • "*" refers to products approved by both WHO and US FDA
  • USFDA1 approved by US FDA
  • USFDA2 tentatively approved by US FDA
  • EMA Art. 58 - approved by EMA according to Article 58

  • Note:
  • For information about the listing of prequalified products and the alternative approval procedure, please see: General Information
  • Click on the WHO REFERENCE NUMBER to see more detailed information

  • Displaying: 51 - 100 of 553
    WHO Reference Number International nonproprietary name (INN) Therapeutic Areasort descending Applicant Dosage form & strength Date of prequalification
    HA575 * Abacavir (sulfate) HIV/AIDS Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 300mg 13 Aug 2015
    HA593 * Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 600mg/300mg/300mg 16 Apr 2015
    HA595 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 4mg 27 Aug 2015
    HA596 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 8mg 27 Aug 2015
    HA597 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 4mg/2mL 21 Oct 2013
    HA598 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 400mg/80mg 23 May 2016
    HA599 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 800mg/160mg 23 May 2016
    HA600 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet 25mg 21 Oct 2013
    HA602 (a) Aciclovir HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Powder for solution for injection 250mg/vial 08 Jan 2014
    HA607 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 8mg/4mL 21 Oct 2013
    HA611 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/300mg/300mg 04 Jun 2015
    HA612 Fluconazole HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 50mg 04 Jun 2015
    HA613 Fluconazole HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 04 Jun 2015
    HA614 Clarithromycin HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 500mg 16 Dec 2015
    HA618 (a) Dexamethasone phosphate HIV/AIDS Kern Pharma SL, Venus 72, Poligono Industrial Colón II, Terrassa, Barcelona, 08228, Spain Solution for injection 4mg 13 Aug 2014
    HA620 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 300mg/300mg 09 Jul 2015
    HA621 Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 25mg 16 Dec 2015
    HA622 Ceftriaxone (sodium) HIV/AIDS Shenzhen Zhijun Pharmaceutical Co Ltd, Workshop I Line III, Hi-Tech Zone, Guanlan, Baoan Area, Shenzhen, Guangdong, China (People's Republic of) Powder for solution for injection 1g 15 Aug 2016
    HA625 Aciclovir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 30 Jun 2017
    HA626 Aciclovir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 400mg 30 Jun 2017
    HA627 Darunavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 21 Dec 2016
    HA628 Darunavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 600mg 21 Dec 2016
    HA629 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg/200mg/300mg 04 May 2019
    HA630 Valganciclovir (hydrochloride) HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 450mg 15 Aug 2018
    HA631 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 200mg/300mg 27 May 2016
    HA632 Atazanavir (sulfate)/Ritonavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg/100mg 21 Apr 2017
    HA633 Efavirenz HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 24 Oct 2017
    HA634 (a) Dolutegravir (Sodium) HIV/AIDS ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands Tablet, Film-coated 50mg 14 Oct 2014
    HA635 Abacavir (sulfate)/Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg/300mg 16 Dec 2015
    HA636 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 10mg 12 Dec 2014
    HA637 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 30mg 12 Dec 2014
    HA638 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 60mg 12 Dec 2014
    HA639 Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 300mg/25mg/800mg/160mg 21 Dec 2016
    HA640 (a) Rifabutin HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Capsules, hard 150mg 17 Nov 2014
    HA641 (a) Fluoxetine (hydrochloride) HIV/AIDS Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland Tablet, Film-coated 20mg 02 Feb 2015
    HA644 Lamivudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg 26 Oct 2016
    HA645 (a) Dapsone HIV/AIDS Jacobus Pharmaceutical Co Inc, PO Box 5290, 37 Cleveland Lane, Princeton, New Jersey, 08540, United States of America Tablet 100mg 13 Jan 2015
    HA650 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 100mg/25mg 19 Jun 2018
    HA655 Lamivudine/Zidovudine HIV/AIDS Shanghai Desano Bio-Pharmaceutical Co Ltd, 1479 Zhangheng Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, 201203, China (People's Republic of) Tablet, Film-coated 150mg/300mg 21 Jul 2017
    HA656 Lamivudine/Zidovudine HIV/AIDS Anhui Biochem Bio-pharmaceutical Co., Ltd., No. 30 Hongfeng Road, Hi-Tech Development Zone, Hefei City, Anhui Province, 230088, China (People's Republic of) Tablet, Film-coated 150mg/300mg 18 Dec 2018
    HA657 Abacavir (sulfate)/Lamivudine HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 600mg/300mg 28 Nov 2017
    HA658 Efavirenz HIV/AIDS Shanghai Desano Bio-Pharmaceutical Co Ltd, 1479 Zhangheng Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, 201203, China (People's Republic of) Tablet, Film-coated 600mg 12 Dec 2017
    HA659 (a) Lamivudine/Zidovudine HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 150mg/300mg 10 Feb 2016
    HA662 Abacavir (sulfate)/Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 120mg/60mg 21 Dec 2016
    HA664 Darunavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 800mg 31 Oct 2018
    HA666 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg/300mg 21 Dec 2016
    HA668 Lamivudine HIV/AIDS Beximco Pharmaceuticals Ltd, 19, Dhanmondi R/A, Road No. 7, Dhaka, 1205, Bangladesh Tablet, Film-coated 300mg 21 Jan 2019
    HA674 Abacavir (sulfate) HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 60mg 30 Jun 2017
    HA678 Dolutegravir (Sodium) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 50mg 31 Oct 2018
    HA679 Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 300mg 12 Dec 2017
    CSVMedicines/Finished Pharmaceutical Products