Medicines/Finished Pharmaceutical Products

E.g., 07/20/2019
E.g., 07/20/2019
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: 301 - 350 of 547
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicantsort descending Dosage form & strength Date of prequalification
    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
    TB226 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 100mg 04 Nov 2013
    TB230 Moxifloxacin (hydrochloride) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 400mg 16 Nov 2012
    TB231 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/300mg 15 Sep 2016
    TB243 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 500mg 04 Dec 2012
    TB259 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 150mg 07 Sep 2016
    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
    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
    TB302 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 50mg/75mg 31 Aug 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
    TB307 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 150mg 07 Dec 2016
    TB309 Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 50mg/150mg/75mg 12 Dec 2017
    TB326 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 22 Feb 2018
    TB330 Cycloserine Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 125mg 17 Jul 2018
    TB332 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 300mg 17 Jul 2018
    TB333 Ethionamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 125mg 30 May 2017
    TB334 Ethambutol hydrochloride Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 14 Mar 2018
    TB337 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 500mg 15 Aug 2018
    TB342 Moxifloxacin (hydrochloride) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 18 Dec 2018
    ANDA 090198b USFDA 2 Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg
    ANDA 090688 USFDA 2 HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated
    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
    HA424 * Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg 14 Dec 2010
    HA459 * Lamivudine/Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/300mg 18 Oct 2011
    HA506 * Efavirenz HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg 04 Dec 2012
    HA513 * Lamivudine/Nevirapine/Zidovudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 150mg/200mg/300mg 24 May 2012
    HA514 * Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 300mg/300mg 10 Apr 2014
    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
    HA523 Lamivudine HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Solution, Oral 10mg/mL 05 Feb 2013
    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
    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
    HA562 Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/200mg/300mg 17 Nov 2014
    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
    HA611 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 600mg/300mg/300mg 04 Jun 2015
    HA334 (a) Indinavir (sulfate) HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Capsules, hard 400mg 23 May 2006
    HA337 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 600mg 23 May 2006
    HA427 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 50mg 14 May 2008
    HA428 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands Tablet, Film-coated 200mg 14 May 2008
    HA338 (a) Efavirenz HIV/AIDS Merck Sharp & Dohme Limited, Hetford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom of Great Britain and Northern Ireland Solution, Oral 30mg 23 May 2006
    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
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