Medicines/Finished Pharmaceutical Products

E.g., 08/17/2019
E.g., 08/17/2019
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: 351 - 400 of 545
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalificationsort descending
    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
    HA553 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 600mg/200mg/300mg 12 Dec 2014
    HA636 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 10mg 12 Dec 2014
    HA637 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 30mg 12 Dec 2014
    HA638 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 60mg 12 Dec 2014
    HA555 Lamivudine/Zidovudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 30mg/60mg 13 Jan 2015
    HA645 (a) Dapsone HIV/AIDS Jacobus Pharmaceutical Co Inc, PO Box 5290, 37 Cleveland Lane, Princeton, New Jersey, 08540, United States of America Tablet 100mg 13 Jan 2015
    HA641 (a) Fluoxetine (hydrochloride) HIV/AIDS Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland Tablet, Film-coated 20mg 02 Feb 2015
    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 Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 200mg/300mg 18 Feb 2015
    HA593 * Efavirenz/Lamivudine/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/300mg/300mg 16 Apr 2015
    RH053 (a) Oxytocin Reproductive Health Grindeks JSC, 53 Krustpils Street, Riga, 1057, Latvia Solution for injection 10iu/mL 16 Apr 2015
    HA611 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/300mg/300mg 04 Jun 2015
    HA612 Fluconazole HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 50mg 04 Jun 2015
    HA613 Fluconazole HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 04 Jun 2015
    HA620 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 300mg/300mg 09 Jul 2015
    RH046 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 1.5mg 09 Jul 2015
    MA108 Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 80mg/480mg 15 Jul 2015
    HA575 * Abacavir (sulfate) HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 300mg 13 Aug 2015
    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
    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
    HA574 Lopinavir/Ritonavir HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 200mg/50mg 09 Sep 2015
    MA093 (a) Dihydroartemisinin/Piperaquine (phosphate) Malaria Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy Tablet, Film-coated 20mg/160mg 09 Oct 2015
    MA094 (a) Dihydroartemisinin/Piperaquine (phosphate) Malaria Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy Tablet, Film-coated 40mg/320mg 09 Oct 2015
    TB276 Isoniazid Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet 300mg 29 Oct 2015
    HA614 Clarithromycin HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 500mg 16 Dec 2015
    HA621 Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 25mg 16 Dec 2015
    HA635 Abacavir (sulfate)/Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg/300mg 16 Dec 2015
    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
    RH058 (a) Levonorgestrel Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 1.5mg 16 Dec 2015
    TB228 Cycloserine Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 250mg 18 Dec 2015
    HA659 (a) Lamivudine/Zidovudine HIV/AIDS Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 150mg/300mg 10 Feb 2016
    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
    RH056 Misoprostol Reproductive Health Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India Tablet 200mcg 27 Apr 2016
    TB211 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 10 May 2016
    HA598 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 400mg/80mg 23 May 2016
    HA599 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 800mg/160mg 23 May 2016
    RH061 (a) Mifepristone Reproductive Health Exelgyn, 216 BOULEVARD SAINT GERMAIN, Paris, 75007, France Tablet 200mg 23 May 2016
    HA631 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 200mg/300mg 27 May 2016
    TB263 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, coated 400mg 11 Jul 2016
    TB299 Linezolid Tuberculosis 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 11 Jul 2016
    HA622 Ceftriaxone (sodium) HIV/AIDS Shenzhen Zhijun Pharmaceutical Co Ltd, Workshop I Line III, Hi-Tech Zone, Guanlan, Baoan Area, Shenzhen, Guangdong, China (People's Republic of) Powder for solution for injection 1g 15 Aug 2016
    RH052 Mifepristone Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mg 15 Aug 2016
    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
    RH062 (a) Magnesium sulphate Reproductive Health Inresa Arzneimittel GmbH, Obere Hardtstraße 18, 79114, Freiburg, Germany Solution for injection 50% 15 Aug 2016
    NT001 (a) Diethylcarbamazine (citrate) Neglected Tropical Diseases (NTD) Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 100mg 06 Sep 2016
    TB259 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 150mg 07 Sep 2016
    TB231 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/300mg 15 Sep 2016
    CSVMedicines/Finished Pharmaceutical Products