Medicines/Finished Pharmaceutical Products

E.g., 08/24/2019
E.g., 08/24/2019
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: 501 - 549 of 549
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strengthsort descending Date of prequalification
    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
    HA633 Efavirenz HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 24 Oct 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
    HA681 Efavirenz HIV/AIDS Government Pharmaceutical Organization (GPO), 75/1 Rama VI Road, Ratchathewi, Bangkok, 10400, Thailand Tablet, Film-coated 600mg 15 Aug 2018
    HA685 Darunavir (ethanolate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg 11 Jun 2019
    HA733 (a) Darunavir HIV/AIDS Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Tablet, Film-coated 600mg 11 Jun 2019
    NT004 Praziquantel Neglected Tropical Diseases (NTD) Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 05 Sep 2017
    HA444 Efavirenz/Emtricitabine/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 600mg/200mg/300mg 25 Oct 2010
    HA500 Efavirenz/Emtricitabine/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/200mg/300mg 08 Dec 2011
    HA538 * Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India Tablet, Film-coated 600mg/200mg/300mg 19 Feb 2014
    HA553 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 600mg/200mg/300mg 12 Dec 2014
    HA562 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/200mg/300mg 17 Nov 2014
    ANDA 90159 USFDA 2 Abacavir (sulfate)/Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet, Film-coated 600mg/300mg
    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
    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
    HA698 Abacavir (sulfate)/Lamivudine HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 600mg/300mg 11 Jun 2019
    HA706 (a) Abacavir (sulfate)/Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 600mg/300mg 19 Jun 2018
    HA466 * Efavirenz/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 600mg/300mg/300mg 25 Oct 2010
    HA549 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 600mg/300mg/300mg 30 Jun 2017
    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
    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
    HA537 Zidovudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 60mg 14 Jun 2013
    HP008 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 60mg 14 Oct 2016
    HP016 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 60mg 15 May 2019
    EMA Art 58 H-W-2319 Artesunate/Pyronaridine (phosphate) Malaria Shin Poong Pharmaceutical Co Ltd, 748-31 Yoksam-Dong, Gangnam-Gu, Seoul, 135-925, Republic of Korea Tablet, Film-coated 60mg/180mg
    NDA 22295 USFDA Abacavir (sulfate)/Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet, Film-coated 60mg/30mg
    TB279 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 750mg 24 Oct 2014
    TB340 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 750mg 15 May 2019
    HA059 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 750mg 20 Mar 2002
    HA529 (a) Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 75mg 11 Sep 2012
    TB068 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 75mg/150mg 19 Dec 2003
    TB158 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 75mg/150mg 07 Mar 2008
    TB189 Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 75mg/150mg 19 Dec 2012
    NDA 207315 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 75mg/75mg
    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
    HA683 Darunavir (ethanolate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 800mg 11 Jun 2019
    HA131 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet, Film-coated 800mg/160mg 29 May 2002
    HA596 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 8mg 27 Aug 2015
    RH013 Ethinylestradiol/Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg 29 Sep 2011
    RH080 (a) Ethinylestradiol/Levonorgestrel Reproductive Health Temmler Pharma GmbH, Temmlerstraße 2, 35039, Marburg, Germany Tablet, Sugar coated 30mcg/150mcg 12 Dec 2017
    RH082 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany (MAH: Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany) Tablet, Sugar coated 30mcg/150mcg + 0mcg 24 Oct 2017
    RH035 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg + 0mg 21 Oct 2013
    MA068 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablets + Tablets 25mg/500mg + 100mg 18 Dec 2018
    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
    NT006 Mebendazole Neglected Tropical Diseases (NTD) Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, 2340, Belgium Tablets, Chewable 500mg 05 Apr 2019
    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
    CSVMedicines/Finished Pharmaceutical Products