Medicines/Finished Pharmaceutical Products

E.g., 06/24/2018
E.g., 06/24/2018
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 525
    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
    MA027 (a) Artemotil Malaria ACE Pharmaceutical BV (Zeewolde NL), Bunsenstrasse 4, Trittau, 22946, Germany Solution for injection 50mg/mL 01 Mar 2006
    MA028 (a) Artemotil Malaria ACE Pharmaceutical BV (Zeewolde NL), Bunsenstrasse 4, Trittau, 22946, Germany Solution for injection 150mg 01 Mar 2006
    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
    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
    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
    TB271 (a) Levofloxacin Tuberculosis Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 250mg 24 Jun 2013
    TB272 (a) Levofloxacin Tuberculosis Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 500mg 24 Jun 2013
    TB273 (a) Levofloxacin Tuberculosis Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 750mg 24 Jun 2013
    HA542 (a) Aciclovir HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 200mg 24 Jun 2013
    HA543 (a) Aciclovir HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 400mg 24 Jun 2013
    HA548 (a) Fluconazole HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 50mg 26 Aug 2013
    HA559 (a) Diazepam HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 2mg 16 Nov 2012
    HA560 (a) Diazepam HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 5mg 16 Nov 2012
    HA577 (a) Amoxicillin/Clavulanic Acid (potassium) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 500mg/125mg 24 Jun 2013
    HA579 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 250mg 24 Jun 2013
    HA580 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 500mg 24 Jun 2013
    HA583 (a) Fluoxetine (hydrochloride) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Capsules, hard 20mg 24 Jun 2013
    HA584 (a) Ondansetron (hydrochloride) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 4mg 24 Jun 2013
    HA585 (a) Ondansetron (hydrochloride) HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet, Film-coated 8mg 24 Jun 2013
    HA586 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 400mg/80mg 24 Jun 2013
    HA587 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 800mg/160mg 24 Jun 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
    HA588 Tenofovir disoproxil fumarate HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet, Film-coated 300mg 07 Dec 2016
    HA601 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet, Film-coated 200mg/300mg 07 Dec 2016
    HA649 Efavirenz HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet, Film-coated 600mg 07 Dec 2016
    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
    CSVMedicines/Finished Pharmaceutical Products