Medicines/Finished Pharmaceutical Products

E.g., 10/23/2019
E.g., 10/23/2019
  • "+" 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: 551 - 554 of 554
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    HA115 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 50mg/5mL 20 Mar 2002
    HA641 (a) Fluoxetine (hydrochloride) HIV/AIDS Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland Tablet, Film-coated 20mg 02 Feb 2015
    TB289 Moxifloxacin (hydrochloride) Tuberculosis Zhejiang Hisun Pharmaceutical Co Ltd, 46 Waisha Road, Jiaojiang District, Taizhou, Zhejiang, 318 000, China (People's Republic of) Tablet, Film-coated 400mg 31 Oct 2018
    ANDA 078644 USFDA 2 Nevirapine HIV/AIDS Zhejiang Huahai Pharmaceutical Co Ltd, Xunqiao, Linhai, Zhejiang Province, 317 024, China (People's Republic of) Tablet 200mg
    CSVMedicines/Finished Pharmaceutical Products