Medicines/Finished Pharmaceutical Products

E.g., 07/20/2019
E.g., 07/20/2019
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: 151 - 200 of 547
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strengthsort descending Date of prequalification
    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
    MA079 Artesunate/Mefloquine (hydrochloride) Malaria Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland Tablet 100mg/200mg 12 Sep 2012
    ANDA 090471a USFDA 2 Lopinavir/Ritonavir HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 100mg/25mg
    ANDA 091677 USFDA 2 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet 100mg/25mg
    MA057 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 135mg/50mg 14 Oct 2008
    MA081 Amodiaquine (hydrochloride)/Artesunate Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet 135mg/50mg 01 Jun 2012
    MA084 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 135mg/50mg 16 Nov 2012
    MA096 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 135mg/50mg 10 Jul 2013
    MA103 Amodiaquine (hydrochloride)/Artesunate Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 135mg/50mg 08 Apr 2014
    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
    MA133 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 135mg/50mg 31 Oct 2018
    ANDA 077464a USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet 150mg
    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
    HCnda Lamivudine/Nevirapine/Zidovudine HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 150mg/200mg/300mg
    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 21837a USFDA Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    NDA 22177 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    NDA 22537 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/200mg/30mg
    NDA 21837b USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/40mg
    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 078929 USFDA 2 Lamivudine/Zidovudine 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 150mg/300mg
    ANDA 079124 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Hetero Labs Ltd, Hetero House, H No 8-3-166/7/1, Erragadda, Hyderabad, Andhra Pradesh, 500 018, India Tablet 150mg/300mg
    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 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 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 22096 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/300mg + 600mg
    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
    NDA 22085a USFDA 2 Lamivudine/Stavudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 150mg/30mg
    NDA 22541 USFDA 2 Lamivudine/Stavudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 150mg/30mg
    NDA 22085b USFDA 2 Lamivudine/Stavudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 150mg/40mg
    NDA 21854 USFDA 2 Lamivudine/Stavudine + Nevirapine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/40mg + 200mg
    RH039 Misoprostol Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mcg 08 Apr 2014
    RH048 Misoprostol Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mcg 22 Nov 2016
    RH056 Misoprostol Reproductive Health Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India Tablet 200mcg 27 Apr 2016
    ANDA 077521 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg
    ANDA 078644 USFDA 2 Nevirapine HIV/AIDS Zhejiang Huahai Pharmaceutical Co Ltd, Xunqiao, Linhai, Zhejiang Province, 317 024, China (People's Republic of) Tablet 200mg
    ANDA 078887 USFDA 2 Nevirapine 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 200mg
    HA039 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mg 20 Mar 2002
    HA155 * Nevirapine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Rangareddy District, Telangana, 500 012, India Tablet 200mg 04 Jul 2003
    HA268 * Nevirapine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet 200mg 01 Apr 2005
    HA298 * Nevirapine HIV/AIDS Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India Tablet 200mg 29 Sep 2005
    HA396 * Nevirapine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 25 Jul 2008
    HA570 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 200mg 19 Feb 2014
    HA613 Fluconazole HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 04 Jun 2015
    HA625 Aciclovir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 30 Jun 2017
    NDA 22461c USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg
    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
    CSVMedicines/Finished Pharmaceutical Products