Medicines/Finished Pharmaceutical Products

E.g., 06/30/2020
E.g., 06/30/2020
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: 301 - 350 of 573
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strengthsort descending Date of prequalification
    TB263 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, coated 400mg 11 Jul 2016
    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
    TB085 (a) Isoniazid/Rifampicin Tuberculosis Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India Tablet, coated 75mg/150mg 14 Sep 2004
    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
    TB326 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 22 Feb 2018
    TB334 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 14 Mar 2018
    TB342 Moxifloxacin (hydrochloride) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 18 Dec 2018
    TB348 Isoniazid Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 100mg 16 Mar 2020
    TB349 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 100mg 31 Oct 2018
    TB356 Levofloxacin Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 100mg 22 Oct 2019
    HA662 Abacavir (sulfate)/Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 120mg/60mg 21 Dec 2016
    TB333 Ethionamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 125mg 30 May 2017
    TB352 Ethionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 125mg 23 Jul 2019
    TB307 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 150mg 07 Dec 2016
    TB335 Pyrazinamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 150mg 26 Sep 2017
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 2012
    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
    DI011 Zinc (sulfate) Diarrhoea Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet, Dispersible 20mg 25 May 2020
    MA069 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet, Dispersible 20mg/120mg 27 Feb 2009
    MA092 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet, Dispersible 20mg/120mg 19 Dec 2012
    MA110 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet, Dispersible 20mg/120mg 12 Dec 2017
    MA115 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 20mg/120mg 17 Jul 2017
    MA136 Artemether/Lumefantrine Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet, Dispersible 20mg/120mg 19 Jun 2018
    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
    MA141 Dihydroartemisinin/Piperaquine (phosphate) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet, Dispersible 20mg/160mg 19 Nov 2019
    HA433 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Dispersible 30mg/50mg/60mg 26 Oct 2009
    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
    NDA 203076 USFDA 2 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/50mg/60mg
    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
    NDA 202814 USFDA 2 Lamivudine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 30mg/60mg
    MA139 Dihydroartemisinin/Piperaquine (phosphate) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet, Dispersible 40mg/320mg 19 Nov 2019
    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
    NDA 22299 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet, Dispersible 50mg
    TB347 Isoniazid Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 50mg 16 Mar 2020
    TB309 Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 50mg/150mg/75mg 12 Dec 2017
    TB302 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 50mg/75mg 31 Aug 2017
    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
    HA674 Abacavir (sulfate) HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 60mg 30 Jun 2017
    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
    ANDA 090688 USFDA 2 HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated
    RH071 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Laboratorios León Farma SA, C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre, León, 24008, Spain Tablet, Film-coated + Tablet, Film-coated 0.03mg/0.15mg + 0mg 21 Apr 2020
    RH057 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 0.03mg 15 Aug 2016
    RH070 Ethinylestradiol/Levonorgestrel Reproductive Health Laboratorios León Farma SA, C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre, León, 24008, Spain Tablet, Film-coated 0.03mg/0.15mg 21 Apr 2020
    HP005 (a) Entecavir Hepatitis Hetero Labs Ltd, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Ranga Reddy District, Telangana, 500 018, India Tablet, Film-coated 0.5mg 28 Nov 2017
    HA056 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 100mg 20 Mar 2002
    HA464 * Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg 30 Mar 2010
    HA467 Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg 14 Dec 2010
    HA491 (a) Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 100mg 01 Jun 2010
    HA532 (a) Etravirine HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 100mg 11 Sep 2012
    NDA 22461b USFDA 2 Efavirenz HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg
    CSVMedicines/Finished Pharmaceutical Products