Medicines/Finished Pharmaceutical Products

E.g., 07/17/2019
E.g., 07/17/2019
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: 251 - 300 of 547
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    TB179 Isoniazid Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 300mg 23 Apr 2008
    TB196 Isoniazid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 100mg 31 Oct 2012
    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
    TB276 Isoniazid Tuberculosis Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet 300mg 29 Oct 2015
    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
    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
    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
    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
    HA639 Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 300mg/25mg/800mg/160mg 21 Dec 2016
    TB189 Isoniazid/Rifampicin Tuberculosis Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands Tablet, Film-coated 75mg/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
    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
    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, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 50mg/75mg 31 Aug 2017
    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
    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
    TB158 Isoniazid/Rifampicin Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 75mg/150mg 07 Mar 2008
    HA704 (a) Itraconazole HIV/AIDS Universal Farma S.L., Gran Via Carlos III, 98, 7th floor, Barcelona, 08028, Spain Capsules, hard 100mg 17 Jul 2018
    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
    TB212 Kanamycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 500mg 17 Jul 2017
    TB213 Kanamycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 17 Jul 2017
    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
    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
    ANDA 077464a USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India Tablet 150mg
    ANDA 077464b USFDA 2 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 300mg
    ANDA 077695 USFDA 1 Lamivudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Solution, Oral 10mg/ml
    ANDA 078545 USFDA 2 Lamivudine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 300mg
    ANDA 078850a USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India Tablet, Film-coated 150mg
    ANDA 078850b USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, Hetero House, H No 8-3-166/7/1, Erragadda, Hyderabad, Andhra Pradesh, 500 018, India Tablet 300mg
    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 090457 USFDA 2 Lamivudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 300mg
    ANDA 091475 USFDA 2 Lamivudine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Solution, Oral 10mg/ml
    HA053 * Lamivudine 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
    HA117 (a) Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 150mg 20 Mar 2002
    HA128 (a) Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 10mg/mL 20 Mar 2002
    HA353 Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 150mg 29 Sep 2010
    HA354 Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg 29 Sep 2010
    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
    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
    HA536 Lamivudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 30mg 18 Feb 2013
    HA644 Lamivudine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg 26 Oct 2016
    HA668 Lamivudine HIV/AIDS Beximco Pharmaceuticals Ltd, 19, Dhanmondi R/A, Road No. 7, Dhaka, 1205, Bangladesh Tablet, Film-coated 300mg 21 Jan 2019
    NDA 21837a USFDA Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    NDA 21837b USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/40mg
    NDA 22177 USFDA 2 Lamivudine/Nevirapine/Stavudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 150mg/200mg/30mg
    CSVMedicines/Finished Pharmaceutical Products