Medicines/Finished Pharmaceutical Products

E.g., 06/01/2020
E.g., 06/01/2020
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 - 550 of 573
    WHO Reference Numbersort descending International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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
    TB236 Cycloserine Tuberculosis Dong-A ST Co Ltd, 64, Cheonho-daero, Dongdaemun-gu, Seoul, 130 708, Republic of Korea Capsules, hard 250mg 12 Nov 2012
    TB237 Levofloxacin Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 03 Oct 2012
    TB238 Levofloxacin Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 500mg 03 Oct 2012
    TB239 Protionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 25 Feb 2013
    TB242 Ethionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 250mg 19 Dec 2012
    TB243 Pyrazinamide Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 500mg 04 Dec 2012
    TB253 Moxifloxacin (hydrochloride) Tuberculosis Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 400mg 04 Nov 2013
    TB259 Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 150mg 07 Sep 2016
    TB263 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, coated 400mg 11 Jul 2016
    TB264 (a) Ethambutol hydrochloride Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet, Film-coated 400mg 28 Feb 2013
    TB265 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 100mg 28 Feb 2013
    TB266 (a) Isoniazid Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 300mg 28 Feb 2013
    TB267 (a) Pyrazinamide Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Tablet 500mg 28 Feb 2013
    TB268 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg 28 Feb 2013
    TB269 (a) Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 300mg 28 Feb 2013
    TB270 (a) Isoniazid/Rifampicin Tuberculosis Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania Capsules, hard 150mg/300mg 28 Feb 2013
    TB276 Isoniazid Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet 300mg 29 Oct 2015
    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
    TB285 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg 26 Sep 2017
    TB286 Moxifloxacin (hydrochloride) Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg 26 Oct 2016
    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
    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
    TB299 Linezolid Tuberculosis Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India Tablet, Film-coated 600mg 11 Jul 2016
    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
    TB304 Cycloserine Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Capsules, hard 250mg 12 Dec 2017
    TB306 Cycloserine Tuberculosis Strides Pharma Science Limited, 3rd & 4th Floor, The Batra Centre, No. 28, Sardar Patel Road, Guindy, Chennai, Tamil Nadu, 600032, India Capsules, hard 250mg 30 Jun 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
    TB308 Isoniazid Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 100mg 26 Sep 2017
    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
    TB311 Moxifloxacin (hydrochloride) Tuberculosis Getz Pharma Pvt Ltd, 29-30/27 Korangi Industrial Area, Karachi, 74900 Tablet, Film-coated 400mg 22 Feb 2019
    TB315 Moxifloxacin (hydrochloride) Tuberculosis Hetero Labs Ltd, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Ranga Reddy District, Telangana, 500 018, India Tablet, Film-coated 400mg 20 Jul 2017
    TB316 Capreomycin (sulfate) Tuberculosis NCPC International Corp., 217-1 East Heping Road, Shijiazhuang, Hebei, 050011, China (People's Republic of) Powder for solution for injection 1g 26 Sep 2017
    TB317 Kanamycin (sulfate) Tuberculosis Shanghai Harvest Pharmaceutical Co., Ltd., No. 805, Jinhu Road, Pudong, Shanghai, China (People's Republic of) Solution for injection 500mg 05 Feb 2020
    TB318 Kanamycin (sulfate) Tuberculosis Shanghai Harvest Pharmaceutical Co., Ltd., No. 805, Jinhu Road, Pudong, Shanghai, China (People's Republic of) Solution for injection 1g 05 Feb 2020
    TB319 Amikacin (sulfate) Tuberculosis Qilu Pharmaceutical Co.,Ltd, No. 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China (People's Republic of) Solution for injection 500mg 11 May 2018
    TB321 Linezolid Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 600mg 07 Dec 2016
    TB323 Linezolid Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 31 Oct 2018
    TB326 Levofloxacin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 22 Feb 2018
    TB327 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 500mg/2ml 06 Feb 2019
    TB328 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 1000mg/3ml 06 Feb 2019
    TB329 Capreomycin (sulfate) Tuberculosis Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot – II, Krishnagiri Road, Hosur, 635 109, India Powder for solution for injection 1g 12 Dec 2017
    TB330 Cycloserine Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 125mg 17 Jul 2018
    TB331 Ethionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 125mg 21 Apr 2017
    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
    CSVMedicines/Finished Pharmaceutical Products