Medicines/Finished Pharmaceutical Products

E.g., 06/21/2018
E.g., 06/21/2018
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: 151 - 200 of 525
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    HA492 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Rangareddy District, Telangana, 500 012, India Tablet, Film-coated 200mg/50mg 11 Jan 2013
    HA493 Abacavir (sulfate) HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Rangareddy District, Telangana, 500 012, India Solution, Oral 20mg/mL 01 Nov 2012
    HA494 * Abacavir (sulfate) HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 22 Dec 2011
    HA498 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 200mg/300mg 24 Jun 2013
    HA500 Efavirenz/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 600mg/200mg/300mg 08 Dec 2011
    HA502 Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 30mg 04 Jul 2012
    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
    HA507 * Atazanavir (sulfate)/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 300mg/100mg 28 Nov 2011
    HA508 * Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 300mg 31 Oct 2012
    HA510 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 50mg 19 Feb 2014
    HA511 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 100mg 19 Feb 2014
    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
    HA515 Gancyclovir (sodium) HIV/AIDS Hainan Poly Pharma Co Ltd, Guilinyang Economic Development Area, Haikou, Hainan, China (People's Republic of) Powder for solution for injection 500mg 20 Dec 2012
    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
    HA518 Abacavir (sulfate)/Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 60mg/30mg 08 Jan 2014
    HA521 Lamivudine/Zidovudine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 150mg/300mg 14 Jun 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
    HA524 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 150mg/200mg/300mg 13 Jun 2014
    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
    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
    HA527 Efavirenz/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 600mg/200mg/300mg 24 Oct 2014
    HA529 (a) Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 75mg 11 Sep 2012
    HA530 (a) Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 150mg 11 Sep 2012
    HA531 Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 600mg 04 Dec 2012
    HA532 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 100mg 11 Sep 2012
    HA535 * Tenofovir disoproxil fumarate HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 21 Oct 2013
    HA536 Lamivudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 30mg 18 Feb 2013
    HA537 Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 60mg 14 Jun 2013
    HA538 * Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India Tablet, Film-coated 600mg/200mg/300mg 19 Feb 2014
    HA542 (a) Aciclovir HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 200mg 24 Jun 2013
    HA543 (a) Aciclovir HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 400mg 24 Jun 2013
    HA548 (a) Fluconazole HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 50mg 26 Aug 2013
    HA549 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 600mg/300mg/300mg 30 Jun 2017
    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
    HA552 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 200mg/300mg 18 Feb 2015
    HA553 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 600mg/200mg/300mg 12 Dec 2014
    HA554 Aciclovir HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet 400mg 12 Dec 2017
    HA555 Lamivudine/Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 30mg/60mg 13 Jan 2015
    HA557 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Dispersible 30mg/50mg/60mg 24 Oct 2014
    HA559 (a) Diazepam HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 2mg 16 Nov 2012
    HA560 (a) Diazepam HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 5mg 16 Nov 2012
    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
    HA567 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 20mg 19 Feb 2014
    HA568 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 50mg 19 Feb 2014
    HA569 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 19 Feb 2014
    HA570 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 200mg 19 Feb 2014
    HA572 * Lamivudine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Dispersible 30mg/60mg 10 Apr 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
    CSVMedicines/Finished Pharmaceutical Products