Medicines/Finished Pharmaceutical Products

E.g., 12/19/2018
E.g., 12/19/2018
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: 1 - 50 of 526
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    HA096 (a) Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL 20 Mar 2002
    HA491 (a) Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 100mg 01 Jun 2010
    HA098 (a) Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL/20mg/mL 20 Mar 2002
    HA381 (a) Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 200mg/50mg 30 Oct 2006
    EMA Art 58 H-W-764-1 Lopinavir/Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 200mg/50mg
    EMA Art 58 H-W-764-2 Lopinavir/Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 100mg/25mg
    RH056 Misoprostol Reproductive Health Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India Tablet 200mcg 27 Apr 2016
    MA092 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet, Dispersible 20mg/120mg 19 Dec 2012
    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
    MA111 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 20mg/120mg 06 Oct 2014
    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
    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
    DI004 Zinc (as sulfate) Diarrhoea Alkem Laboratories Ltd, Alkem House, "Devashish" Senapati Bapat Marg, Lower Parel, Mumbai, 400 013, India Tablet, Dispersible 20mg 19 Feb 2014
    HA656 Lamivudine/Zidovudine HIV/AIDS Anhui Biochem Bio-pharmaceutical Co., Ltd., No. 30 Hongfeng Road, Hi-Tech Development Zone, Hefei City, Anhui Province, 230088, China (People's Republic of) Tablet, Film-coated 150mg/300mg 18 Dec 2018
    TB264 (a) Ethambutol hydrochloride Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet, Film-coated 400mg 28 Feb 2013
    TB265 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 100mg 28 Feb 2013
    TB266 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 300mg 28 Feb 2013
    TB267 (a) Pyrazinamide Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 500mg 28 Feb 2013
    TB268 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg 28 Feb 2013
    TB269 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 300mg 28 Feb 2013
    TB270 (a) Isoniazid/Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg/300mg 28 Feb 2013
    HCnda Lamivudine/Nevirapine/Zidovudine HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 150mg/200mg/300mg
    RH063 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (2ml) 04 Jul 2017
    RH064 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (10ml) 04 Jul 2017
    NDA 21841 USFDA 2 Lamivudine/Zidovudine + Nevirapine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet 150mg/300mg + 200mg
    NDA 22018 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet 150mg/300mg
    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
    NDA 21939 USFDA 2 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/200mg/300mg
    NDA 21944 USFDA 2 Lamivudine/Zidovudine + Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 300mg
    NDA 22296 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 30mg/60mg
    NDA 22299 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet, Dispersible 50mg
    NDA 22343 USFDA 2 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 600mg/300mg/300mg
    NDA 22344 USFDA 2 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg/300mg
    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
    ANDA 077267 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077268 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    ANDA 077275b USFDA 2 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablets, Chewable 100mg
    ANDA 077275c USFDA 2 Didanosine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablets, Chewable 150mg
    ANDA 077464b USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077521 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg
    ANDA 077558 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg
    ANDA 077672a USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 15mg
    ANDA 077672b USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 20mg
    ANDA 077672c USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 30mg
    ANDA 077672d USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 40mg
    CSVMedicines/Finished Pharmaceutical Products