Medicines/Finished Pharmaceutical Products

E.g., 07/18/2019
E.g., 07/18/2019
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: 351 - 400 of 547
    WHO Reference Number International nonproprietary name (INN) Therapeutic Areasort descending Applicant Dosage form & strength Date of prequalification
    MA096 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 135mg/50mg 10 Jul 2013
    MA097 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 270mg/100mg 10 Jul 2013
    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
    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
    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
    MA108 Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 80mg/480mg 15 Jul 2015
    MA110 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet, Dispersible 20mg/120mg 12 Dec 2017
    MA111 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 20mg/120mg 06 Oct 2014
    MA113 Pyrimethamine/Sulfadoxine Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet 25mg/500mg 31 Oct 2018
    MA115 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 20mg/120mg 17 Jul 2017
    MA116 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 12.5mg/250mg + 76.5mg 21 Aug 2018
    MA117 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 25mg/500mg + 153mg 21 Aug 2018
    MA120 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 40mg/240mg 17 Jul 2017
    MA121 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 60mg/360mg 17 Jul 2017
    MA122 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 80mg/480mg 17 Jul 2017
    MA123 Artesunate Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Capsule, Soft, Rectal 100mg 19 Jun 2018
    MA124 Artesunate Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsule, Soft, Rectal 100mg 22 Feb 2018
    MA125 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 67.5mg/25mg 15 May 2019
    MA126 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 135mg/50mg 15 May 2019
    MA127 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 270mg/100mg 15 May 2019
    MA128 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 40mg/240mg 21 Apr 2017
    MA129 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 60mg/360mg 21 Apr 2017
    MA130 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 80mg/480mg 21 Apr 2017
    MA132 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 67.5mg/25mg 31 Oct 2018
    MA133 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 135mg/50mg 31 Oct 2018
    MA134 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 270mg/100mg 31 Oct 2018
    MA135 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Powder, solvent and diluent for solution for injection 60mg + 5%w/v + 0.9%w/v 18 Dec 2018
    MA136 Artemether/Lumefantrine Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet, Dispersible 20mg/120mg 19 Jun 2018
    MA138 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 80mg/480mg 06 Feb 2019
    EMA Art 58 H-W-002320 Fexinidazole Neglected Tropical Diseases (NTD) Sanofi-aventis groupe, 54 rue de la Boétie, Paris, 75008, France Tablet 600mg
    NT001 (a) Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 100mg 06 Sep 2016
    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
    NT003 Praziquantel Neglected Tropical Diseases (NTD) Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 600mg 16 Dec 2015
    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
    NT006 Mebendazole Neglected Tropical Diseases (NTD) Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, 2340, Belgium Tablets, Chewable 500mg 05 Apr 2019
    RH002 (a) Levonorgestrel Reproductive Health Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany Tablet, coated 30mcg 26 May 2009
    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
    RH017 (a) Levonorgestrel Reproductive Health Bayer Pharma AG, Müllerstraße 178, Berlin, 13353, Germany Rod 75mg 23 Sep 2009
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    RH021 (a) Lynestrenol Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Tablet 500mcg 02 Jun 2010
    RH022 (a) Norethisterone enantate Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany Solution for injection 200mg/ml 05 Oct 2011
    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
    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
    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
    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
    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
    CSVMedicines/Finished Pharmaceutical Products