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: 401 - 450 of 547
    WHO Reference Number International nonproprietary name (INN)sort descending Therapeutic Area Applicant Dosage form & strength Date of prequalification
    RH073 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 2ml 12 Dec 2017
    RH077 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 10mL 12 Dec 2017
    RH062 (a) Magnesium sulphate Reproductive Health Inresa Arzneimittel GmbH, Obere Hardtstraße 18, 79114, Freiburg, Germany Solution for injection 50% 15 Aug 2016
    RH072 (a) Magnesium sulphate Reproductive Health Labesfal, Laboratorios Almiro SA, Unit 2, Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal Solution for injection 500mg/ml (10ml) 19 Jun 2018
    NT006 Mebendazole Neglected Tropical Diseases (NTD) Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, 2340, Belgium Tablets, Chewable 500mg 05 Apr 2019
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    RH074 Medroxyprogesterone acetate Reproductive Health Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India Suspension for injection 150mg 31 Oct 2018
    RH075 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Limited, Ramsgate Rd., Sandwich, Kent, CT13 9NJ, United Kingdom of Great Britain and Northern Ireland Suspension for injection 104mg/0.65ml 28 Nov 2017
    RH051 (a) Mifepristone Reproductive Health Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland Tablet 200mg 06 Oct 2014
    RH052 Mifepristone Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mg 15 Aug 2016
    RH061 (a) Mifepristone Reproductive Health Exelgyn, 216 BOULEVARD SAINT GERMAIN, Paris, 75007, France Tablet 200mg 23 May 2016
    RH039 Misoprostol Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mcg 08 Apr 2014
    RH048 Misoprostol Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mcg 22 Nov 2016
    RH056 Misoprostol Reproductive Health Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India Tablet 200mcg 27 Apr 2016
    HA636 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 10mg 12 Dec 2014
    HA637 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 30mg 12 Dec 2014
    HA638 (a) Morphine hydrochloride HIV/AIDS GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria Tablets, Prolonged release 60mg 12 Dec 2014
    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
    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
    TB263 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, coated 400mg 11 Jul 2016
    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
    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
    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
    TB349 Moxifloxacin (hydrochloride) Tuberculosis Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 100mg 31 Oct 2018
    NDA 22299 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet, Dispersible 50mg
    ANDA 077521 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Tablet 200mg
    ANDA 077702 USFDA 2 Nevirapine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Suspension, Oral 50mg/5ml
    ANDA 078644 USFDA 2 Nevirapine HIV/AIDS Zhejiang Huahai Pharmaceutical Co Ltd, Xunqiao, Linhai, Zhejiang Province, 317 024, China (People's Republic of) Tablet 200mg
    ANDA 078887 USFDA 2 Nevirapine HIV/AIDS Emcure Pharmaceuticals Ltd, Plot No P-2, ITBT Park Phase II, M.I.D.C., Hinjwadi, Pune District, Maharashtra, 411 057, India Tablet 200mg
    HA039 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mg 20 Mar 2002
    HA155 * Nevirapine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Rangareddy District, Telangana, 500 012, India Tablet 200mg 04 Jul 2003
    HA200 Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Suspension, Oral 50mg/5mL 25 May 2009
    HA268 * Nevirapine HIV/AIDS Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Tablet 200mg 01 Apr 2005
    HA298 * Nevirapine HIV/AIDS Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India Tablet 200mg 29 Sep 2005
    HA396 * Nevirapine HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 200mg 25 Jul 2008
    HA510 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 50mg 19 Feb 2014
    HA511 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Dispersible 100mg 19 Feb 2014
    HA567 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 20mg 19 Feb 2014
    HA568 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 50mg 19 Feb 2014
    HA569 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 100mg 19 Feb 2014
    HA570 Nevirapine HIV/AIDS Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 200mg 19 Feb 2014
    RH043 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 26 Aug 2013
    RH045 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 21 Oct 2013
    RH022 (a) Norethisterone enantate Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany Solution for injection 200mg/ml 05 Oct 2011
    TB224 Ofloxacin Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 200mg 22 Dec 2011
    TB225 Ofloxacin Tuberculosis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 22 Dec 2011
    HA595 Ondansetron (hydrochloride) HIV/AIDS Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India Tablet, Film-coated 4mg 27 Aug 2015
    CSVMedicines/Finished Pharmaceutical Products