Medicines/Finished Pharmaceutical Products

E.g., 08/21/2019
E.g., 08/21/2019
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: 401 - 450 of 545
    WHO Reference Number International nonproprietary name (INN)sort ascending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    NT002 Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Eisai Co Ltd, 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, 112-8088, Japan Tablet 100mg 20 Aug 2013
    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 90094a USFDA 1 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 125mg
    ANDA 90094b USFDA 1 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 400mg
    ANDA 90094c USFDA 1 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 200mg
    ANDA 90094d USFDA 1 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 250mg
    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
    RH025 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 0.150mg/0.030mg + 0mg 29 Sep 2010
    RH044 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mg 21 Oct 2013
    RH049 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mcg 08 Apr 2014
    RH037 (a) Desogestrel/Ethinylestradiol Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 0.150mg/0.030mg 14 Aug 2013
    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
    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
    HA529 (a) Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 75mg 11 Sep 2012
    HA530 (a) Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 150mg 11 Sep 2012
    HA531 Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 600mg 04 Dec 2012
    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
    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
    HA733 (a) Darunavir HIV/AIDS Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Tablet, Film-coated 600mg 11 Jun 2019
    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
    HP007 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 30mg 14 Oct 2016
    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
    HP015 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 30mg 15 May 2019
    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
    TB222 Cycloserine Tuberculosis Biocom JSC, 54 Chapaevsky Crescent, Stavropol, 355 016, Russian Federation Capsules, hard 250mg 20 Aug 2013
    TB228 Cycloserine Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 250mg 18 Dec 2015
    TB236 Cycloserine Tuberculosis Dong-A ST Co Ltd, 64, Cheonho-daero, Dongdaemun-gu, Seoul, 130 708, Republic of Korea Capsules, hard 250mg 12 Nov 2012
    TB304 Cycloserine Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 250mg 12 Dec 2017
    TB306 Cycloserine Tuberculosis Strides Pharma Science Limited, 3rd & 4th Floor, The Batra Centre, No. 28, Sardar Patel Road, Guindy, Chennai, Tamil Nadu, 600032, India Capsules, hard 250mg 30 Jun 2017
    TB330 Cycloserine Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 125mg 17 Jul 2018
    TB154 Cycloserine Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 250mg 23 Mar 2007
    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
    HA056 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 100mg 20 Mar 2002
    HA057 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 250mg 20 Mar 2002
    HA058 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 500mg 20 Mar 2002
    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
    HA716 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 250mg 18 Dec 2018
    HA738 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 500mg 11 Jun 2019
    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
    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
    HA479 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 1000mg 16 May 2014
    HA480 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 500mg 16 May 2014
    TB211 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 10 May 2016
    TB261 Capreomycin (sulfate) Tuberculosis Hisun Pharmaceutical (Hangzhou) Co Ltd, Xialian Village, Xukou Town, Hangzhou City, Zhejiang Province 311404, People’s Republic of China Powder for solution for injection 1000mg 06 Oct 2014
    TB316 Capreomycin (sulfate) Tuberculosis NCPC International Corp., 217-1 East Heping Road, Shijiazhuang, Hebei, 050011, China (People's Republic of) Powder for solution for injection 1g 26 Sep 2017
    TB329 Capreomycin (sulfate) Tuberculosis Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot – II, Krishnagiri Road, Hosur, 635 109, India Powder for solution for injection 1g 12 Dec 2017
    TB337 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 500mg 15 Aug 2018
    HA507 * Atazanavir (sulfate)/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 300mg/100mg 28 Nov 2011
    CSVMedicines/Finished Pharmaceutical Products