Medicines/Finished Pharmaceutical Products

E.g., 08/23/2019
E.g., 08/23/2019
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: 501 - 549 of 549
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    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
    HA291 * Lamivudine/Zidovudine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 150mg/300mg 30 Jun 2006
    HA389 * Efavirenz HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 200mg 24 Feb 2009
    HA390 * Efavirenz HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, coated 600mg 24 Feb 2009
    HA494 * Abacavir (sulfate) HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 22 Dec 2011
    HA524 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 150mg/200mg/300mg 13 Jun 2014
    HA535 * Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 21 Oct 2013
    HA552 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 200mg/300mg 18 Feb 2015
    HA553 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 600mg/200mg/300mg 12 Dec 2014
    HA557 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Dispersible 30mg/50mg/60mg 24 Oct 2014
    IN002 Oseltamivir (phosphate) Influenza Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Capsules, hard 75mg 25 Oct 2010
    ANDA 090457 USFDA 2 Lamivudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 300mg
    ANDA 21988 USFDA Lamivudine/Zidovudine + Nevirapine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India - 150mg/300mg + 200mg
    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 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
    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
    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 22097 USFDA 2 Lamivudine/Stavudine + Efavirenz HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India ; Tablet + Tablet; 150mg/40mg + 600mg
    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
    TB253 Moxifloxacin (hydrochloride) Tuberculosis Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 400mg 04 Nov 2013
    HA525 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 300mg/300mg 11 Sep 2012
    HA551 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 200mg/300mg 12 Feb 2015
    HA698 Abacavir (sulfate)/Lamivudine HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 600mg/300mg 11 Jun 2019
    HA286 Lamivudine/Zidovudine HIV/AIDS Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India Tablet, Film-coated 150mg/300mg 11 Aug 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
    HA306 Efavirenz HIV/AIDS Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India Tablet, Film-coated 600mg 23 May 2006
    HA323 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India Tablet, Film-coated 150mg/200mg/300mg 07 Mar 2008
    TB189 Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 75mg/150mg 19 Dec 2012
    TB192 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/150mg 19 Dec 2012
    TB193 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/400mg/150mg 19 Dec 2012
    RH080 (a) Ethinylestradiol/Levonorgestrel Reproductive Health Temmler Pharma GmbH, Temmlerstraße 2, 35039, Marburg, Germany Tablet, Sugar coated 30mcg/150mcg 12 Dec 2017
    HA716 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 250mg 18 Dec 2018
    HA738 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 500mg 11 Jun 2019
    HA490 Lamivudine/Zidovudine HIV/AIDS Universal Corporation Ltd, PO Box 1748, Club Road, Plot No 13777, Kikuyu, 902, Kenya Tablet, Film-coated 150mg/300mg 21 Oct 2011
    HA704 (a) Itraconazole HIV/AIDS Universal Farma S.L., Gran Via Carlos III, 98, 7th floor, Barcelona, 08028, Spain Capsules, hard 100mg 17 Jul 2018
    HA117 (a) Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 150mg 20 Mar 2002
    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
    HA706 (a) Abacavir (sulfate)/Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 600mg/300mg 19 Jun 2018
    HA106 (a) Abacavir (sulfate) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 300mg 20 Mar 2002
    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
    HA108 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 100mg 29 May 2002
    HA109 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 250mg 29 May 2002
    HA110 (a) Lamivudine/Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 150mg/300mg 20 Mar 2002
    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
    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
    HA634 (a) Dolutegravir (Sodium) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 50mg 14 Oct 2014
    HA641 (a) Fluoxetine (hydrochloride) HIV/AIDS Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland Tablet, Film-coated 20mg 02 Feb 2015
    TB289 Moxifloxacin (hydrochloride) Tuberculosis Zhejiang Hisun Pharmaceutical Co Ltd, 46 Waisha Road, Jiaojiang District, Taizhou, Zhejiang, 318 000, China (People's Republic of) Tablet, Film-coated 400mg 31 Oct 2018
    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
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