Medicines/Finished Pharmaceutical Products

E.g., 07/17/2019
E.g., 07/17/2019
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: 201 - 250 of 547
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    HA417 * 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 200mg/300mg 20 Aug 2010
    HA439 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 200mg/300mg 05 Oct 2011
    HA498 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 200mg/300mg 24 Jun 2013
    HA551 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 200mg/300mg 12 Feb 2015
    HA552 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 200mg/300mg 18 Feb 2015
    HA561 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 200mg/300mg 08 Apr 2014
    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
    HP005 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 0.5mg 28 Nov 2017
    HP006 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 1mg 28 Nov 2017
    TB008 Ethambutol hydrochloride Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, coated 400mg 13 Nov 2003
    TB134 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 400mg 23 Mar 2007
    TB177 Ethambutol hydrochloride Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg 08 Apr 2010
    TB226 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 100mg 04 Nov 2013
    TB264 (a) Ethambutol hydrochloride Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet, Film-coated 400mg 28 Feb 2013
    TB334 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 14 Mar 2018
    TB009 Ethambutol hydrochloride/Isoniazid Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 400mg/150mg 28 Apr 2010
    TB198
    (suspended)
    Ethambutol hydrochloride/Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg/150mg 19 Dec 2012
    TB070 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/400mg/150mg 13 Nov 2003
    TB090 (a) Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India Tablet, Film-coated 275mg/75mg/400mg/150mg 14 Sep 2004
    TB168 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 275mg/75mg/400mg/150mg 07 Mar 2008
    TB193 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/400mg/150mg 19 Dec 2012
    TB223 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Micro Labs Ltd, ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area, Bangalore, 560 074, India Tablet, Film-coated 275mg/75mg/400mg/150mg 07 Dec 2016
    TB183 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 275mg/75mg/150mg 22 Oct 2008
    TB192 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/150mg 19 Dec 2012
    TB199 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/150mg 11 Jan 2013
    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
    RH038 Ethinylestradiol/Levonorgestrel + Ferrous Fumarate Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Ethinylestradiol/Levonorgestrel Tablet + Placebo (Ferrous Fumarate Tablet) 30mcg/150mcg + 75mg 11 Mar 2014
    RH030 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.150mg + 0mg 22 Dec 2011
    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
    RH041 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH042 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablets + Placebo Tablets 0.03mg/0.15mg + 0mg 26 Aug 2013
    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
    TB133 Ethionamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 250mg 21 Dec 2007
    TB207 Ethionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 250mg 19 Dec 2012
    TB215 Ethionamide Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 250mg 22 Dec 2011
    TB242 Ethionamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 19 Dec 2012
    TB331 Ethionamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 125mg 21 Apr 2017
    TB333 Ethionamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 125mg 30 May 2017
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    HA532 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 100mg 11 Sep 2012
    HA600 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet 25mg 21 Oct 2013
    EMA Art 58 H-W-002320 Fexinidazole Neglected Tropical Diseases (NTD) Sanofi-aventis groupe, 54 rue de la Boétie, Paris, 75008, France Tablet 600mg
    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
    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
    HA641 (a) Fluoxetine (hydrochloride) HIV/AIDS Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland Tablet, Film-coated 20mg 02 Feb 2015
    HA515 Ganciclovir (sodium) HIV/AIDS Hainan Poly Pharma Co Ltd, Guilinyang Economic Development Area, Haikou, Hainan, China (People's Republic of) Powder for solution for injection 500mg 20 Dec 2012
    HA334 (a) Indinavir (sulfate) HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Capsules, hard 400mg 23 May 2006
    TB173 Isoniazid Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 01 Nov 2010
    CSVMedicines/Finished Pharmaceutical Products