Medicines/Finished Pharmaceutical Products

E.g., 09/20/2019
E.g., 09/20/2019
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: 451 - 500 of 551
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    RH032 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 750mcg 14 Jun 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
    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
    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
    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
    TB285 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg 26 Sep 2017
    TB286 Moxifloxacin (hydrochloride) Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg 26 Oct 2016
    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
    TB308 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 100mg 26 Sep 2017
    TB324 Protionamide Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 250mg 26 Sep 2017
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    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
    TB296 Streptomycin (sulfate) - Sterile Tuberculosis NCPC International Corp., 217-1 East Heping Road, Shijiazhuang, Hebei, China (People's Republic of) Powder for solution for injection 1g 30 Jun 2017
    MA026 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 20mg/120mg 26 Apr 2004
    MA069 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet, Dispersible 20mg/120mg 27 Feb 2009
    MA108 Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 80mg/480mg 15 Jul 2015
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 2012
    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
    TB229 (a) Para-aminosalicylate (sodium) Tuberculosis OlainFarm JSC, 5 Rupnicu Street, Olaine, 2114, Latvia Powder for Oral solution 4g 22 Mar 2011
    RH075 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Limited, Ramsgate Rd., Sandwich, Kent, CT13 9NJ, United Kingdom of Great Britain and Northern Ireland Suspension for injection 104mg/0.65ml 28 Nov 2017
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    RH050 Oxytocin Reproductive Health PT Sanbe Farma, Jl. Taman Sari No 10, Bandung, 40116, Indonesia Solution for injection 10IU/mL 30 Jun 2017
    TB354 Levofloxacin Tuberculosis PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia Tablet, Film-coated 500mg 22 Feb 2019
    TB319 Amikacin (sulfate) Tuberculosis Qilu Pharmaceutical Co.,Ltd, No. 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China (People's Republic of) Solution for injection 500mg 11 May 2018
    TB345 (a) Protionamide Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Tablet, Film-coated 250mg 14 Mar 2018
    TB346 (a) Terizidone Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Capsules, hard 250mg 14 Mar 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
    IN003 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Powder for Oral suspension 12mg/mL 21 Sep 2009
    IN004 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 30mg 21 Sep 2009
    IN005 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 45mg 21 Sep 2009
    IN006 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 75mg 21 Sep 2009
    TB085 (a) Isoniazid/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, coated 75mg/150mg 14 Sep 2004
    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
    MA056 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 67.5mg/25mg 14 Oct 2008
    MA057 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 135mg/50mg 14 Oct 2008
    MA058 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 270mg/100mg 14 Oct 2008
    MA087 Artemether Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Solution for injection 80mg/ml 29 Aug 2019
    NT001 (a) Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 100mg 06 Sep 2016
    TB336 (a) Rifapentine Tuberculosis Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet, Film-coated 150mg 14 Feb 2017
    EMA Art 58 H-W-002320 Fexinidazole Neglected Tropical Diseases (NTD) Sanofi-aventis groupe, 54 rue de la Boétie, Paris, 75008, France Tablet 600mg
    RH028 Levonorgestrel Reproductive Health Shanghai Dahua Pharmaceutical Co Ltd, 3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai, China (People's Republic of) Implant 75mg per rod (150mg in total) 30 Jun 2017
    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
    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
    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
    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
    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
    EMA Art 58 H-W-2319-3 Artesunate/Pyronaridine (phosphate) Malaria Shin Poong Pharmaceutical Co Ltd, 748-31 Yoksam-Dong, Gangnam-Gu, Seoul, 135-925, Republic of Korea Granules for Oral suspension 20mg/60mg
    MA088 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 20mg/120mg 24 Jun 2013
    MA110 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet, Dispersible 20mg/120mg 12 Dec 2017
    MA123 Artesunate Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Capsule, Soft, Rectal 100mg 19 Jun 2018
    CSVMedicines/Finished Pharmaceutical Products