Medicines/Finished Pharmaceutical Products

E.g., 04/22/2019
E.g., 04/22/2019
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: 1 - 8 of 8
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    ANDA 090513 USFDA 2 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg/300mg
    HA417 * Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 200mg/300mg 20 Aug 2010
    HA439 Emtricitabine/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 200mg/300mg 05 Oct 2011
    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
    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
    HA561 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 200mg/300mg 08 Apr 2014
    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
    CSVMedicines/Finished Pharmaceutical Products