Medicines/Finished Pharmaceutical Products

E.g., 08/18/2019
E.g., 08/18/2019
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: 101 - 150 of 545
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strengthsort descending Date of prequalification
    RH050 Oxytocin Reproductive Health PT Sanbe Farma, Jl. Taman Sari No 10, Bandung, 40116, Indonesia Solution for injection 10IU/mL 30 Jun 2017
    RH053 (a) Oxytocin Reproductive Health Grindeks JSC, 53 Krustpils Street, Riga, 1057, Latvia Solution for injection 10iu/mL 16 Apr 2015
    HA114 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution for injection 10mg/mL 20 Mar 2002
    RH022 (a) Norethisterone enantate Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany Solution for injection 200mg/ml 05 Oct 2011
    HA618 (a) Dexamethasone phosphate HIV/AIDS Kern Pharma SL, Venus 72, Poligono Industrial Colón II, Terrassa, Barcelona, 08228, Spain Solution for injection 4mg 13 Aug 2014
    HA597 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 4mg/2mL 21 Oct 2013
    RH062 (a) Magnesium sulphate Reproductive Health Inresa Arzneimittel GmbH, Obere Hardtstraße 18, 79114, Freiburg, Germany Solution for injection 50% 15 Aug 2016
    RH077 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 10mL 12 Dec 2017
    RH073 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 2ml 12 Dec 2017
    TB319 Amikacin (sulfate) Tuberculosis Qilu Pharmaceutical Co.,Ltd, No. 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China (People's Republic of) Solution for injection 500mg 11 May 2018
    TB327 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 500mg/2ml 06 Feb 2019
    TB343 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 500mg/2ml 24 Jan 2019
    RH064 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (10ml) 04 Jul 2017
    RH072 (a) Magnesium sulphate Reproductive Health Labesfal, Laboratorios Almiro SA, Unit 2, Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal Solution for injection 500mg/ml (10ml) 19 Jun 2018
    RH063 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (2ml) 04 Jul 2017
    HA607 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 8mg/4mL 21 Oct 2013
    HA486 Zidovudine HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Solution, Oral 10mg 03 Nov 2011
    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 077695 USFDA 1 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    ANDA 091475 USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Solution, Oral 10mg/ml
    HA128 (a) Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 10mg/mL 20 Mar 2002
    HA523 Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Solution, Oral 10mg/mL 05 Feb 2013
    HA526 Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Solution, Oral 10mg/mL 14 Jun 2013
    ANDA 077950 USFDA 2 Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 20mg/ml
    HA107 (a) Abacavir (sulfate) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 20mg/mL 20 Mar 2002
    HA493 Abacavir (sulfate) HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 012, India Solution, Oral 20mg/mL 01 Nov 2012
    HA338 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme Limited, Hetford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom of Great Britain and Northern Ireland Solution, Oral 30mg 23 May 2006
    HA053 * Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Solution, Oral 50mg/5mL 20 Mar 2002
    HA054 * Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Solution, Oral 50mg/5mL 20 Mar 2002
    HA115 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 50mg/5mL 20 Mar 2002
    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
    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
    RH075 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Limited, Ramsgate Rd., Sandwich, Kent, CT13 9NJ, United Kingdom of Great Britain and Northern Ireland Suspension for injection 104mg/0.65ml 28 Nov 2017
    RH074 Medroxyprogesterone acetate Reproductive Health Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India Suspension for injection 150mg 31 Oct 2018
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    ANDA 077702 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Suspension, Oral 50mg/5ml
    HA200 Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Suspension, Oral 50mg/5mL 25 May 2009
    HA130 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Syrup 40mg/mL/8mg/mL 28 Feb 2003
    RH037 (a) Desogestrel/Ethinylestradiol Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 0.150mg/0.030mg 14 Aug 2013
    RH031 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 1.5mg 21 Oct 2013
    RH046 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 1.5mg 09 Jul 2015
    RH058 (a) Levonorgestrel Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 1.5mg 16 Dec 2015
    RH065 Levonorgestrel Reproductive Health HLL Lifecare Limited, Unipill Block, Kanagala, Belgaum, Karnataka, 591225, India Tablet 1.5mg 23 Apr 2018
    NT001 (a) Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 100mg 06 Sep 2016
    NT002 Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Eisai Co Ltd, 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, 112-8088, Japan Tablet 100mg 20 Aug 2013
    TB173 Isoniazid Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 01 Nov 2010
    TB178 Isoniazid Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 100mg 23 Apr 2008
    TB196 Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 100mg 31 Oct 2012
    TB265 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 100mg 28 Feb 2013
    TB308 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 100mg 26 Sep 2017
    CSVMedicines/Finished Pharmaceutical Products