Medicines/Finished Pharmaceutical Products

E.g., 09/24/2018
E.g., 09/24/2018
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: 101 - 150 of 533
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    HA286 Lamivudine/Zidovudine HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet, Film-coated 150mg/300mg 11 Aug 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
    HA298 * Nevirapine HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet 200mg 29 Sep 2005
    HA306 Efavirenz HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet, Film-coated 600mg 23 May 2006
    HA323 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet, Film-coated 150mg/200mg/300mg 07 Mar 2008
    HA329 (a) Tenofovir disoproxil fumarate HIV/AIDS Gilead Sciences Inc, 333 Lakeside Drive, Foster City, California, 94404, United States of America Tablet, Film-coated 300mg 01 Mar 2006
    HA334 (a) Indinavir (sulfate) HIV/AIDS Merck Sharp & Dohme Limited, Hetford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom of Great Britain and Northern Ireland Capsules, hard 400mg 23 May 2006
    HA337 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 600mg 23 May 2006
    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
    HA343 (a) Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Gilead Sciences Inc, 333 Lakeside Drive, Foster City, California, 94404, United States of America Tablet, Film-coated 200mg/300mg 23 May 2006
    HA352 * Efavirenz HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 600mg 16 Dec 2008
    HA353 Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 150mg 29 Sep 2010
    HA354 Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg 29 Sep 2010
    HA365 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 150mg/200mg/300mg 10 Mar 2009
    HA371 * Abacavir (sulfate) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 300mg 23 Apr 2008
    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
    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
    HA392 * Lamivudine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 150mg/300mg 23 Apr 2008
    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
    HA399 * Efavirenz HIV/AIDS Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 600mg 01 Jul 2009
    HA401 * Tenofovir disoproxil fumarate HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg 30 Jun 2009
    HA403 * Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg 25 Jul 2008
    HA410 * Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 300mg 27 Oct 2009
    HA411 * Lopinavir/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 200mg/50mg 19 Feb 2009
    HA414 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 300mg/300mg 30 Jun 2010
    HA417 * Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 200mg/300mg 20 Aug 2010
    HA421 (a) Atazanavir (sulfate) HIV/AIDS Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Capsules, hard 150mg 07 Mar 2008
    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
    HA426 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 150mg/200mg/300mg 24 Feb 2009
    HA427 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 50mg 14 May 2008
    HA428 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 200mg 14 May 2008
    HA429 Lopinavir/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 100mg/25mg 25 May 2009
    HA433 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Dispersible 30mg/50mg/60mg 26 Oct 2009
    HA437 * Lamivudine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 30mg/60mg 25 May 2009
    HA439 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 200mg/300mg 05 Oct 2011
    HA444 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg/200mg/300mg 25 Oct 2010
    HA448 * Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet 300mg/300mg 01 Sep 2011
    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
    HA464 * Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 100mg 30 Mar 2010
    HA466 * Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg/300mg/300mg 25 Oct 2010
    HA467 Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 100mg 14 Dec 2010
    HA479 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 1000mg 16 May 2014
    HA480 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 500mg 16 May 2014
    HA483 Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 300mg 20 Aug 2010
    HA485 Lamivudine/Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg/300mg 25 Oct 2010
    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
    HA488 Abacavir (sulfate) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 60mg 20 Aug 2010
    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
    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
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