Medicines/Finished Pharmaceutical Products

E.g., 04/21/2019
E.g., 04/21/2019
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: 201 - 250 of 534
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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, 27 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
    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, 27 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, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 24 Oct 2017
    HA634 (a) Dolutegravir (Sodium) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland 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, 27 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, 27 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
    HA680 Dolutegravir (Sodium) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 50mg 24 Oct 2017
    HA681 Efavirenz HIV/AIDS Government Pharmaceutical Organization (GPO), 75/1 Rama VI Road, Ratchathewi, Bangkok, 10400, Thailand Tablet, Film-coated 600mg 15 Aug 2018
    HA682 Dolutegravir (Sodium) HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 50mg 17 Jul 2018
    HA684 Lamivudine/Nevirapine/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/200mg/300mg 20 Sep 2018
    HA686 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 400mg/80mg 05 Apr 2019
    HA687 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 800mg/160mg 05 Apr 2019
    HA688 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil (fumarate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 50mg/300mg/300mg 18 Dec 2018
    HA692 (a) Ceftriaxone (sodium) HIV/AIDS Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom of Great Britain and Northern Ireland Powder for solution for injection 1g 22 Feb 2018
    HA693 (a) Flucytosine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 500mg 14 Mar 2018
    HA702 Dolutegravir (Sodium)/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 50mg/300mg/300mg 05 Apr 2019
    HA704 (a) Itraconazole HIV/AIDS Universal Farma S.L., Gran Via Carlos III, 98, 7th floor, Barcelona, 08028, Spain Capsules, hard 100mg 17 Jul 2018
    HA705 (a) Amphotericin B HIV/AIDS Gilead Sciences International Ltd, Flowers Building, Granta Park, Abington, Cambridge, CB21 6GT, United Kingdom of Great Britain and Northern Ireland Powder for concentration for dispersion for infusion 50mg 19 Jun 2018
    CSVMedicines/Finished Pharmaceutical Products