Medicines/Finished Pharmaceutical Products

E.g., 06/16/2019
E.g., 06/16/2019
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 - 546 of 546
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    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
    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
    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
    TB300 Kanamycin (acid sulfate) Tuberculosis Hisun Pharmaceutical (Hangzhou) Co Ltd, Xialian Village, Xukou Town, Hangzhou City, Zhejiang Province 311404, People’s Republic of China Powder for solution for injection 500mg 19 Jun 2018
    TB301 Kanamycin (acid sulfate) Tuberculosis Hisun Pharmaceutical (Hangzhou) Co Ltd, Xialian Village, Xukou Town, Hangzhou City, Zhejiang Province 311404, People’s Republic of China Powder for solution for injection 1g 19 Jun 2018
    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, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, 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
    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, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 600mg 31 Oct 2018
    TB324 Protionamide Tuberculosis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 250mg 26 Sep 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
    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, 27 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
    TB335 Pyrazinamide Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 150mg 26 Sep 2017
    TB336 (a) Rifapentine Tuberculosis Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet, Film-coated 150mg 14 Feb 2017
    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
    TB338 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 250mg 15 May 2019
    TB339 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 500mg 15 May 2019
    TB340 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 750mg 15 May 2019
    TB341 Moxifloxacin (hydrochloride) Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 400mg 19 Jun 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
    TB343 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 500mg/2ml 24 Jan 2019
    TB344 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 1000mg/3ml 24 Jan 2019
    TB345 (a) Protionamide Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Tablet, Film-coated 250mg 14 Mar 2018
    TB346 (a) Terizidone Tuberculosis RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany Capsules, hard 250mg 14 Mar 2018
    TB349 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 100mg 31 Oct 2018
    TB350 Linezolid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 600mg 18 Dec 2018
    TB351 Linezolid Tuberculosis Celltrion Inc., 23 Academy-ro,, Yeonsu-gu, Incheon, 22014, Republic of Korea Tablet, Film-coated 600mg 06 Feb 2019
    TB354 Levofloxacin Tuberculosis PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia Tablet, Film-coated 500mg 22 Feb 2019
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