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: 351 - 400 of 549
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    HA656 Lamivudine/Zidovudine HIV/AIDS Anhui Biochem Bio-pharmaceutical Co., Ltd., No. 30 Hongfeng Road, Hi-Tech Development Zone, Hefei City, Anhui Province, 230088, China (People's Republic of) Tablet, Film-coated 150mg/300mg 18 Dec 2018
    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
    NDA 21944 USFDA 2 Lamivudine/Zidovudine + Abacavir (sulfate) HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 300mg
    NDA 22096 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/300mg + 600mg
    NDA 21943 USFDA 2 Lamivudine/Zidovudine + Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 150mg/300mg + 600mg
    NDA 21841 USFDA 2 Lamivudine/Zidovudine + Nevirapine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet 150mg/300mg + 200mg
    ANDA 21988 USFDA Lamivudine/Zidovudine + Nevirapine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India - 150mg/300mg + 200mg
    TB205 Levofloxacin Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 250mg 22 Dec 2011
    TB227 Levofloxacin Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 500mg 22 Dec 2011
    TB237 Levofloxacin Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 03 Oct 2012
    TB238 Levofloxacin Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 500mg 03 Oct 2012
    TB277 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 250mg 24 Oct 2014
    TB278 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 500mg 24 Oct 2014
    TB279 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 750mg 24 Oct 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
    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
    TB354 Levofloxacin Tuberculosis PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia Tablet, Film-coated 500mg 22 Feb 2019
    RH002 (a) Levonorgestrel Reproductive Health Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany Tablet, coated 30mcg 26 May 2009
    RH017 (a) Levonorgestrel Reproductive Health Bayer Pharma AG, Müllerstraße 178, Berlin, 13353, Germany Rod 75mg 23 Sep 2009
    RH028 Levonorgestrel Reproductive Health Shanghai Dahua Pharmaceutical Co Ltd, 3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai, China (People's Republic of) Implant 75mg per rod (150mg in total) 30 Jun 2017
    RH031 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 1.5mg 21 Oct 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
    RH040 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 750mcg 08 Apr 2014
    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
    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
    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
    RH065 Levonorgestrel Reproductive Health HLL Lifecare Limited, Unipill Block, Kanagala, Belgaum, Karnataka, 591225, India Tablet 1.5mg 23 Apr 2018
    TB297 Linezolid Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 12 Dec 2017
    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
    TB321 Linezolid Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 600mg 07 Dec 2016
    TB323 Linezolid Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 31 Oct 2018
    TB350 Linezolid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 600mg 18 Dec 2018
    TB351 Linezolid Tuberculosis Celltrion Inc., 23 Academy-ro,, Yeonsu-gu, Incheon, 22014, Republic of Korea Tablet, Film-coated 600mg 06 Feb 2019
    ANDA 090471a USFDA 2 Lopinavir/Ritonavir HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 100mg/25mg
    ANDA 090471b USFDA 2 Lopinavir/Ritonavir HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg/50mg
    ANDA 091677 USFDA 2 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet 100mg/25mg
    ANDA 90371 USFDA 2 Lopinavir/Ritonavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 200mg/50mg
    EMA Art 58 H-W-764-1 Lopinavir/Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 200mg/50mg
    EMA Art 58 H-W-764-2 Lopinavir/Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 100mg/25mg
    HA098 (a) Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, AbbVie House, Vanwall Road, Maidenhead, SL6 4UB, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL/20mg/mL 20 Mar 2002
    HA381 (a) Lopinavir/Ritonavir HIV/AIDS AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, Germany Tablet, Film-coated 200mg/50mg 30 Oct 2006
    HA411 * Lopinavir/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 200mg/50mg 19 Feb 2009
    HA429 Lopinavir/Ritonavir HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg/25mg 25 May 2009
    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
    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
    HA650 Lopinavir/Ritonavir HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 100mg/25mg 19 Jun 2018
    RH021 (a) Lynestrenol Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Tablet 500mcg 02 Jun 2010
    CSVMedicines/Finished Pharmaceutical Products