Medicines/Finished Pharmaceutical Products

E.g., 08/23/2019
E.g., 08/23/2019
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: 51 - 100 of 549
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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
    HA705 (a) Amphotericin B HIV/AIDS Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Powder for concentration for dispersion for infusion 50mg 19 Jun 2018
    MA026 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 20mg/120mg 26 Apr 2004
    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
    MA069 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet, Dispersible 20mg/120mg 27 Feb 2009
    MA088 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 20mg/120mg 24 Jun 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
    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
    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
    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
    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
    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
    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
    MA137 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 20mg/120mg 22 Aug 2019
    MA138 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 80mg/480mg 06 Feb 2019
    MA142 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 80mg/480mg 22 Aug 2019
    MA143 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 40mg/240mg 22 Aug 2019
    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
    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
    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
    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
    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
    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
    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
    ANDA 0091611a USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 150mg
    ANDA 0091611b USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 300mg
    ANDA 078785a USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 100mg
    ANDA 078785b USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 200mg
    ANDA 078785c USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 150mg
    ANDA 200196 USFDA 2 Atazanavir (sulfate) HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Capsules, hard 300mg
    HA421 (a) Atazanavir (sulfate) HIV/AIDS Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Capsules, hard 150mg 07 Mar 2008
    HA632 Atazanavir (sulfate)/Ritonavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg/100mg 21 Apr 2017
    NDA 205508 USFDA 2 Atazanavir (sulfate)/Ritonavir HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Tablet 300mg/100mg
    HA507 * Atazanavir (sulfate)/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 300mg/100mg 28 Nov 2011
    TB211 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 10 May 2016
    CSVMedicines/Finished Pharmaceutical Products