Medicines/Finished Pharmaceutical Products

E.g., 01/20/2018
E.g., 01/20/2018
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 - 21 of 21
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    TB009 Ethambutol hydrochloride/Isoniazid Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 400mg/150mg 28 Apr 2010
    TB068 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 75mg/150mg 19 Dec 2003
    TB070 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/400mg/150mg 13 Nov 2003
    TB085 (a) Isoniazid/Rifampicin Tuberculosis Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India Tablet, coated 75mg/150mg 14 Sep 2004
    TB090 (a) Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India Tablet, Film-coated 275mg/75mg/400mg/150mg 14 Sep 2004
    TB158 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Film-coated 75mg/150mg 07 Mar 2008
    TB168 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Film-coated 275mg/75mg/400mg/150mg 07 Mar 2008
    TB183 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Film-coated 275mg/75mg/150mg 22 Oct 2008
    TB184 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Dispersible 30mg/60mg 02 Jul 2012
    TB185 Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Dispersible 30mg/150mg/60mg 02 Jul 2012
    TB189 Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 75mg/150mg 19 Dec 2012
    TB192 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/150mg 19 Dec 2012
    TB193 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 275mg/75mg/400mg/150mg 19 Dec 2012
    TB195 Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 150mg/150mg 29 Jan 2013
    TB198
    (suspended)
    Ethambutol hydrochloride/Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 400mg/150mg 19 Dec 2012
    TB199 Ethambutol hydrochloride/Isoniazid/Rifampicin Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 275mg/75mg/150mg 11 Jan 2013
    TB223 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Micro Labs Ltd, ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area, Bangalore, 560 074, India Tablet, Film-coated 275mg/75mg/400mg/150mg 07 Dec 2016
    TB231 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Film-coated 150mg/300mg 15 Sep 2016
    TB270 (a) Isoniazid/Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg/300mg 28 Feb 2013
    TB302 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Dispersible 50mg/75mg 31 Aug 2017
    TB309 Isoniazid/Pyrazinamide/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Dispersible 50mg/150mg/75mg 12 Dec 2017
    CSVMedicines/Finished Pharmaceutical Products