Medicines/Finished Pharmaceutical Products

E.g., 08/25/2019
E.g., 08/25/2019
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: 451 - 500 of 549
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    TB225 Ofloxacin Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 22 Dec 2011
    HA595 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 4mg 27 Aug 2015
    HA596 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 8mg 27 Aug 2015
    HA597 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 4mg/2mL 21 Oct 2013
    HA607 (a) Ondansetron (hydrochloride) HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Solution for injection 8mg/4mL 21 Oct 2013
    IN001 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 75mg 13 May 2009
    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
    IN003 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Powder for Oral suspension 12mg/mL 21 Sep 2009
    IN004 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 30mg 21 Sep 2009
    IN005 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 45mg 21 Sep 2009
    IN006 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 75mg 21 Sep 2009
    IN009 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 30mg 13 Jun 2014
    IN010 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 45mg 13 Jun 2014
    IN011 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 75mg 13 Jun 2014
    IN012 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 30mg 10 Feb 2016
    IN013 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 45mg 10 Feb 2016
    IN014 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 30mg 21 Dec 2016
    IN015 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 45mg 21 Dec 2016
    IN016 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 75mg 21 Dec 2016
    RH050 Oxytocin Reproductive Health PT Sanbe Farma, Jl. Taman Sari No 10, Bandung, 40116, Indonesia Solution for injection 10IU/mL 30 Jun 2017
    RH053 (a) Oxytocin Reproductive Health Grindeks JSC, 53 Krustpils Street, Riga, 1057, Latvia Solution for injection 10iu/mL 16 Apr 2015
    TB156 Para-aminosalicylate (sodium) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Granules, Gastro-resistant 60g/100g 14 Dec 2009
    TB229 (a) Para-aminosalicylate (sodium) Tuberculosis OlainFarm JSC, 5 Rupnicu Street, Olaine, 2114, Latvia Powder for Oral solution 4g 22 Mar 2011
    NT003 Praziquantel Neglected Tropical Diseases (NTD) Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 600mg 16 Dec 2015
    NT004 Praziquantel Neglected Tropical Diseases (NTD) Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 05 Sep 2017
    TB206 Protionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 250mg 13 Jun 2014
    TB239 Protionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 25 Feb 2013
    TB324 Protionamide Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 250mg 26 Sep 2017
    TB345 (a) Protionamide Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Tablet, Film-coated 250mg 14 Mar 2018
    TB015 Pyrazinamide Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet 400mg 13 Nov 2003
    TB159 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 400mg 23 Mar 2007
    TB171 Pyrazinamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 400mg 29 Jun 2009
    TB172 Pyrazinamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 500mg 29 Jun 2009
    TB243 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 500mg 04 Dec 2012
    TB267 (a) Pyrazinamide Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 500mg 28 Feb 2013
    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
    MA113 Pyrimethamine/Sulfadoxine Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet 25mg/500mg 31 Oct 2018
    MA098 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine Tablets + Amodiaquine (hydrochloride) Film coated Tablets 25mg/500mg + 150mg 20 Oct 2014
    MA116 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 12.5mg/250mg + 76.5mg 21 Aug 2018
    MA117 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 25mg/500mg + 153mg 21 Aug 2018
    MA066 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Pyrimethamine/Suphadoxine Tablet + Artesunate Tablet 25mg/500mg + 50mg 24 May 2012
    MA068 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablets + Tablets 25mg/500mg + 100mg 18 Dec 2018
    HA640 (a) Rifabutin HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Capsules, hard 150mg 17 Nov 2014
    TB259 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 150mg 07 Sep 2016
    TB268 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg 28 Feb 2013
    TB269 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 300mg 28 Feb 2013
    TB332 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 300mg 17 Jul 2018
    TB336 (a) Rifapentine Tuberculosis Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet, Film-coated 150mg 14 Feb 2017
    HA096 (a) Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL 20 Mar 2002
    CSVMedicines/Finished Pharmaceutical Products