Medicines/Finished Pharmaceutical Products

E.g., 08/25/2019
E.g., 08/25/2019
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: 251 - 300 of 549
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    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
    ANDA 210963 USFDA Dolutegravir (Sodium) HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 50mg
    HA679 Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 300mg 12 Dec 2017
    HA717 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 200mg/300mg 22 Aug 2019
    NDA 210787 USFDA 2 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 50mg/300mg/300mg
    RH051 (a) Mifepristone Reproductive Health Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland Tablet 200mg 06 Oct 2014
    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
    TB328 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 1000mg/3ml 06 Feb 2019
    HA640 (a) Rifabutin HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Capsules, hard 150mg 17 Nov 2014
    HA659 (a) Lamivudine/Zidovudine HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 150mg/300mg 10 Feb 2016
    RH041 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH042 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablets + Placebo Tablets 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH043 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 26 Aug 2013
    RH044 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mg 21 Oct 2013
    RH045 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 21 Oct 2013
    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
    TB068 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 75mg/150mg 19 Dec 2003
    TB070 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/400mg/150mg 13 Nov 2003
    TB177 Ethambutol hydrochloride Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg 08 Apr 2010
    TB195 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 150mg/150mg 29 Jan 2013
    TB196 Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 100mg 31 Oct 2012
    TB198
    (suspended)
    Ethambutol hydrochloride/Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg/150mg 19 Dec 2012
    TB199 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/150mg 11 Jan 2013
    TB206 Protionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 250mg 13 Jun 2014
    TB207 Ethionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 250mg 19 Dec 2012
    TB350 Linezolid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 600mg 18 Dec 2018
    ANDA 090198b USFDA 2 Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg
    ANDA 090688 USFDA 2 HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated
    DI005 Zinc sulfate Diarrhoea Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 20mg 07 Dec 2016
    HA424 * Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg 14 Dec 2010
    HA459 * Lamivudine/Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/300mg 18 Oct 2011
    HA506 * Efavirenz HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 04 Dec 2012
    HA513 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/200mg/300mg 24 May 2012
    HA514 * Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg/300mg 10 Apr 2014
    HA516 Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg 23 May 2013
    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
    HA561 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 200mg/300mg 08 Apr 2014
    HA562 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/200mg/300mg 17 Nov 2014
    HA573 Lopinavir/Ritonavir HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 100mg/25mg 09 Sep 2015
    HA574 Lopinavir/Ritonavir HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 200mg/50mg 09 Sep 2015
    HA611 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/300mg/300mg 04 Jun 2015
    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
    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
    MA125 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 67.5mg/25mg 15 May 2019
    MA126 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 135mg/50mg 15 May 2019
    MA127 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 270mg/100mg 15 May 2019
    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
    CSVMedicines/Finished Pharmaceutical Products