Medicines/Finished Pharmaceutical Products

E.g., 08/19/2019
E.g., 08/19/2019
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 545
    WHO Reference Numbersort descending International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    MA081 Amodiaquine (hydrochloride)/Artesunate Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet 135mg/50mg 01 Jun 2012
    MA082 Amodiaquine (hydrochloride)/Artesunate Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet 270mg/100mg 01 Jun 2012
    MA083 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 67.5mg/25mg 16 Nov 2012
    MA084 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 135mg/50mg 16 Nov 2012
    MA085 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 270mg/100mg 16 Nov 2012
    MA088 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 20mg/120mg 24 Jun 2013
    MA089 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Artesunate Powder for Injection + Sodium bicarbonate Solvent solution for Injection + Sodium Chloride Solvent Solution for Injection 30mg/vial + 5%m/v + 0.9%m/v 23 May 2013
    MA090 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Artesunate Powder for injection + Sodium bicarbonate Solvent solution for injection + Sodium Chloride Solvent Solution for Injection 120mg/vial + 5%m/v + 0.9%m/v 23 May 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
    MA092 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet, Dispersible 20mg/120mg 19 Dec 2012
    MA093 (a) Dihydroartemisinin/Piperaquine (phosphate) Malaria Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy Tablet, Film-coated 20mg/160mg 09 Oct 2015
    MA094 (a) Dihydroartemisinin/Piperaquine (phosphate) Malaria Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy Tablet, Film-coated 40mg/320mg 09 Oct 2015
    MA095 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 67.5mg/25mg 10 Jul 2013
    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, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 67.5mg/25mg 31 Oct 2018
    MA133 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 135mg/50mg 31 Oct 2018
    MA134 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 31 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
    NDA 200733 USFDA 2 Abacavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 60mg
    NDA 202381 USFDA 2 Abacavir (sulfate)/Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 60mg/30mg
    NDA 202814 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/60mg
    NDA 203076 USFDA 2 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/50mg/60mg
    NDA 204505 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate + Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg/300mg + 200mg
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