Medicines/Finished Pharmaceutical Products

E.g., 07/17/2019
E.g., 07/17/2019
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 547
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    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
    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
    HA598 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 400mg/80mg 23 May 2016
    HA599 Sulfamethoxazole/Trimethoprim HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 800mg/160mg 23 May 2016
    HA620 Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 300mg/300mg 09 Jul 2015
    HA629 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg/200mg/300mg 04 May 2019
    HA631 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 200mg/300mg 27 May 2016
    HA633 Efavirenz HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 24 Oct 2017
    HA644 Lamivudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg 26 Oct 2016
    HA674 Abacavir (sulfate) HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 60mg 30 Jun 2017
    MA132 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 67.5mg/25mg 31 Oct 2018
    MA133 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 135mg/50mg 31 Oct 2018
    MA134 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 270mg/100mg 31 Oct 2018
    TB171 Pyrazinamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 400mg 29 Jun 2009
    TB172 Pyrazinamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 500mg 29 Jun 2009
    TB173 Isoniazid Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 01 Nov 2010
    TB174 Isoniazid Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 300mg 01 Nov 2010
    TB237 Levofloxacin Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 03 Oct 2012
    TB238 Levofloxacin Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 500mg 03 Oct 2012
    TB239 Protionamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 25 Feb 2013
    TB242 Ethionamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 19 Dec 2012
    TB263 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, coated 400mg 11 Jul 2016
    TB223 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Micro Labs Ltd, ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area, Bangalore, 560 074, India Tablet, Film-coated 275mg/75mg/400mg/150mg 07 Dec 2016
    TB338 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 250mg 15 May 2019
    TB339 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 500mg 15 May 2019
    TB340 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 750mg 15 May 2019
    TB341 Moxifloxacin (hydrochloride) Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 400mg 19 Jun 2018
    TB329 Capreomycin (sulfate) Tuberculosis Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot – II, Krishnagiri Road, Hosur, 635 109, India Powder for solution for injection 1g 12 Dec 2017
    RH074 Medroxyprogesterone acetate Reproductive Health Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India Suspension for injection 150mg 31 Oct 2018
    TB343 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 500mg/2ml 24 Jan 2019
    TB344 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 1000mg/3ml 24 Jan 2019
    HA467 Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 100mg 14 Dec 2010
    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
    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
    HP001 Sofosbuvir Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 400mg 20 Jul 2017
    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
    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
    TB285 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg 26 Sep 2017
    TB286 Moxifloxacin (hydrochloride) Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg 26 Oct 2016
    TB304 Cycloserine Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 250mg 12 Dec 2017
    TB308 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 100mg 26 Sep 2017
    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
    ANDA 0091611a USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 150mg
    ANDA 0091611b USFDA 2 Atazanavir (sulfate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 300mg
    ANDA 078545 USFDA 2 Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    CSVMedicines/Finished Pharmaceutical Products