Medicines/Finished Pharmaceutical Products

E.g., 08/22/2019
E.g., 08/22/2019
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: 251 - 300 of 545
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalificationsort descending
    HA493 Abacavir (sulfate) HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 012, India Solution, Oral 20mg/mL 01 Nov 2012
    TB236 Cycloserine Tuberculosis Dong-A ST Co Ltd, 64, Cheonho-daero, Dongdaemun-gu, Seoul, 130 708, Republic of Korea Capsules, hard 250mg 12 Nov 2012
    MA083 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 67.5mg/25mg 16 Nov 2012
    MA084 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 135mg/50mg 16 Nov 2012
    MA085 Amodiaquine (hydrochloride)/Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Tablet 270mg/100mg 16 Nov 2012
    TB230 Moxifloxacin (hydrochloride) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 400mg 16 Nov 2012
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 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
    HA531 Darunavir HIV/AIDS Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium Tablet, Film-coated 600mg 04 Dec 2012
    TB243 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 500mg 04 Dec 2012
    MA092 Artemether/Lumefantrine Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet, Dispersible 20mg/120mg 19 Dec 2012
    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
    TB198
    (suspended)
    Ethambutol hydrochloride/Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg/150mg 19 Dec 2012
    TB207 Ethionamide Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 250mg 19 Dec 2012
    TB242 Ethionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 19 Dec 2012
    HA515 Ganciclovir (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
    HA492 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 200mg/50mg 11 Jan 2013
    TB199 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/150mg 11 Jan 2013
    TB195 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 150mg/150mg 29 Jan 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
    HA536 Lamivudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 30mg 18 Feb 2013
    TB239 Protionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 25 Feb 2013
    TB264 (a) Ethambutol hydrochloride Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet, Film-coated 400mg 28 Feb 2013
    TB265 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 100mg 28 Feb 2013
    TB266 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 300mg 28 Feb 2013
    TB267 (a) Pyrazinamide Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 500mg 28 Feb 2013
    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
    TB270 (a) Isoniazid/Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg/300mg 28 Feb 2013
    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
    MA089 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Artesunate Powder for Injection + Sodium bicarbonate Solvent solution for Injection + Sodium Chloride Solvent Solution for Injection 30mg/vial + 5%m/v + 0.9%m/v 23 May 2013
    MA090 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of) Artesunate Powder for injection + Sodium bicarbonate Solvent solution for injection + Sodium Chloride Solvent Solution for Injection 120mg/vial + 5%m/v + 0.9%m/v 23 May 2013
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    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
    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
    HA537 Zidovudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 60mg 14 Jun 2013
    RH032 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 750mcg 14 Jun 2013
    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
    MA088 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 20mg/120mg 24 Jun 2013
    MA095 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 67.5mg/25mg 10 Jul 2013
    MA096 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 135mg/50mg 10 Jul 2013
    MA097 Amodiaquine (hydrochloride)/Artesunate Malaria Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India Tablet 270mg/100mg 10 Jul 2013
    RH037 (a) Desogestrel/Ethinylestradiol Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 0.150mg/0.030mg 14 Aug 2013
    NT002 Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Eisai Co Ltd, 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, 112-8088, Japan Tablet 100mg 20 Aug 2013
    TB222 Cycloserine Tuberculosis Biocom JSC, 54 Chapaevsky Crescent, Stavropol, 355 016, Russian Federation Capsules, hard 250mg 20 Aug 2013
    RH041 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH042 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablets + Placebo Tablets 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH043 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 26 Aug 2013
    CSVMedicines/Finished Pharmaceutical Products