Medicines/Finished Pharmaceutical Products

E.g., 07/22/2019
E.g., 07/22/2019
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: 501 - 547 of 547
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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
    HP002 Sofosbuvir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 400mg 07 Feb 2018
    HP003 Sofosbuvir Hepatitis European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt Tablet, Film-coated 400mg 18 Dec 2018
    HP004 Sofosbuvir Hepatitis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 05 Sep 2017
    HP024 (a) Sofosbuvir/Velpatasvir Hepatitis Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Tablet, Film-coated 400mg/100mg 06 Feb 2019
    ANDA 077672a USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 15mg
    ANDA 077672b USFDA 1 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 20mg
    ANDA 077672c USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 30mg
    ANDA 077672d USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 40mg
    ANDA 077774 USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Powder for Oral solution 1mg/ml
    TB214 Streptomycin (sulfate) - Sterile Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 16 May 2019
    TB296 Streptomycin (sulfate) - Sterile Tuberculosis NCPC International Corp., 217-1 East Heping Road, Shijiazhuang, Hebei, China (People's Republic of) Powder for solution for injection 1g 30 Jun 2017
    HA130 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Syrup 40mg/mL/8mg/mL 28 Feb 2003
    HA131 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet, Film-coated 800mg/160mg 29 May 2002
    HA132 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet 400mg/80mg 16 Dec 2002
    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
    HA686 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 400mg/80mg 05 Apr 2019
    HA687 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 800mg/160mg 05 Apr 2019
    ANDA 090647 USFDA 2 Tenofovir disoproxil fumarate HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    HA401 * 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 300mg 30 Jun 2009
    HA410 * 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 300mg 27 Oct 2009
    HA508 * Tenofovir disoproxil fumarate HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 300mg 31 Oct 2012
    HA516 Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg 23 May 2013
    HA535 * Tenofovir disoproxil fumarate HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 300mg 21 Oct 2013
    HA679 Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 300mg 12 Dec 2017
    TB303 Terizidone Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 250mg 28 Nov 2017
    TB346 (a) Terizidone Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Capsules, hard 250mg 14 Mar 2018
    HA630 Valganciclovir (hydrochloride) HIV/AIDS Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 450mg 15 Aug 2018
    IN007 (a) Zanamivir Influenza Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, United Kingdom of Great Britain and Northern Ireland Powder, for Inhalation 5mg 22 Sep 2009
    ANDA 077267 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077268 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    ANDA 078128 USFDA 1 Zidovudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 100mg
    ANDA 078922 USFDA 1 Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    HA054 * Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Solution, Oral 50mg/5mL 20 Mar 2002
    HA108 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 100mg 29 May 2002
    HA109 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 250mg 29 May 2002
    HA114 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution for injection 10mg/mL 20 Mar 2002
    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
    HA464 * Zidovudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 100mg 30 Mar 2010
    HA483 Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 300mg 20 Aug 2010
    HA486 Zidovudine HIV/AIDS Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Solution, Oral 10mg 03 Nov 2011
    HA526 Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Solution, Oral 10mg/mL 14 Jun 2013
    HA537 Zidovudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 60mg 14 Jun 2013
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 2012
    DI005 Zinc sulfate Diarrhoea Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 20mg 07 Dec 2016
    CSVMedicines/Finished Pharmaceutical Products