Medicines/Finished Pharmaceutical Products

E.g., 07/23/2019
E.g., 07/23/2019
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 548
    WHO Reference Number International nonproprietary name (INN) Therapeutic Areasort descending Applicant Dosage form & strength Date of prequalification
    NDA 22461c USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg
    NDA 22537 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/200mg/30mg
    NDA 22541 USFDA 2 Lamivudine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/30mg
    NDA 21943 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 600mg
    IN001 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 75mg 13 May 2009
    IN002 Oseltamivir (phosphate) Influenza Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Capsules, hard 75mg 25 Oct 2010
    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
    IN007 (a) Zanamivir Influenza Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, United Kingdom of Great Britain and Northern Ireland Powder, for Inhalation 5mg 22 Sep 2009
    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
    IN012 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 30mg 10 Feb 2016
    IN013 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 45mg 10 Feb 2016
    IN014 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 30mg 21 Dec 2016
    IN015 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 45mg 21 Dec 2016
    IN016 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 75mg 21 Dec 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
    MA026 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 20mg/120mg 26 Apr 2004
    MA044 Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Tablet 50mg 21 Dec 2005
    MA045 Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet, Film-coated 150mg 30 Aug 2007
    MA046 Amodiaquine (hydrochloride) + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Amodiaquine (Hydrochloride) Tablet + Artesunate Tablet 150mg + 50mg 30 Aug 2007
    MA051 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) - (Vial + Ampoule) ; 60mg/vial + 50mg/ml + 45mg/5ml 05 Nov 2010
    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
    MA062 Artemether/Lumefantrine Malaria Ipca Laboratories Ltd, Plot No 142, Kandivli Industrial Estate, Kandivli (W), Mumbai, Maharashtra, 400 067, India Tablet 20mg/120mg 15 Dec 2009
    MA064 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 20mg/120mg 22 May 2009
    MA066 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Pyrimethamine/Suphadoxine Tablet + Artesunate Tablet 25mg/500mg + 50mg 24 May 2012
    MA068 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablets + Tablets 25mg/500mg + 100mg 18 Dec 2018
    MA069 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet, Dispersible 20mg/120mg 27 Feb 2009
    MA078 Artesunate/Mefloquine (hydrochloride) Malaria Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland Tablet 25mg/50mg 12 Sep 2012
    MA079 Artesunate/Mefloquine (hydrochloride) Malaria Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland Tablet 100mg/200mg 12 Sep 2012
    MA080 Amodiaquine (hydrochloride)/Artesunate Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet 67.5mg/25mg 01 Jun 2012
    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
    CSVMedicines/Finished Pharmaceutical Products