Medicines/Finished Pharmaceutical Products

E.g., 07/15/2019
E.g., 07/15/2019
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: 301 - 350 of 547
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalificationsort descending
    HA535 * Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 21 Oct 2013
    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
    HA600 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet 25mg 21 Oct 2013
    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
    MA091 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 20mg/120mg 21 Oct 2013
    RH031 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 1.5mg 21 Oct 2013
    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
    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
    RH045 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 21 Oct 2013
    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
    TB253 Moxifloxacin (hydrochloride) Tuberculosis Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 400mg 04 Nov 2013
    HA518 Abacavir (sulfate)/Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 60mg/30mg 08 Jan 2014
    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
    HA510 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 50mg 19 Feb 2014
    HA511 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 100mg 19 Feb 2014
    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
    HA567 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 20mg 19 Feb 2014
    HA568 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 50mg 19 Feb 2014
    HA569 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 19 Feb 2014
    HA570 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 200mg 19 Feb 2014
    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
    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
    MA102 Amodiaquine (hydrochloride)/Artesunate Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 67.5mg/25mg 08 Apr 2014
    MA103 Amodiaquine (hydrochloride)/Artesunate Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 135mg/50mg 08 Apr 2014
    MA104 Amodiaquine (hydrochloride)/Artesunate Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 270mg/100mg 08 Apr 2014
    RH039 Misoprostol Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mcg 08 Apr 2014
    RH040 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 750mcg 08 Apr 2014
    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
    HA514 * Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg/300mg 10 Apr 2014
    HA572 * Lamivudine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Dispersible 30mg/60mg 10 Apr 2014
    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
    MA099 Artemether/Lumefantrine Malaria Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 20mg/120mg 16 May 2014
    MA100 Artemether/Lumefantrine Malaria Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 40mg/240mg 16 May 2014
    HA524 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 150mg/200mg/300mg 13 Jun 2014
    IN009 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 30mg 13 Jun 2014
    IN010 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 45mg 13 Jun 2014
    IN011 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 75mg 13 Jun 2014
    TB206 Protionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 250mg 13 Jun 2014
    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
    MA111 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 20mg/120mg 06 Oct 2014
    RH051 (a) Mifepristone Reproductive Health Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland Tablet 200mg 06 Oct 2014
    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
    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
    MA098 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine Tablets + Amodiaquine (hydrochloride) Film coated Tablets 25mg/500mg + 150mg 20 Oct 2014
    HA527 Efavirenz/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 600mg/200mg/300mg 24 Oct 2014
    HA557 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Dispersible 30mg/50mg/60mg 24 Oct 2014
    TB277 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 250mg 24 Oct 2014
    TB278 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 500mg 24 Oct 2014
    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
    CSVMedicines/Finished Pharmaceutical Products