Medicines/Finished Pharmaceutical Products

E.g., 06/20/2019
E.g., 06/20/2019
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: 51 - 100 of 546
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strengthsort descending Date of prequalification
    ANDA 077672d USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 40mg
    IN005 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 45mg 21 Sep 2009
    IN010 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 45mg 13 Jun 2014
    IN013 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 45mg 10 Feb 2016
    IN015 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 45mg 21 Dec 2016
    ANDA 078064a USFDA 2 Efavirenz HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Capsules, hard 50mg
    IN001 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 75mg 13 May 2009
    IN002 Oseltamivir (phosphate) Influenza Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Capsules, hard 75mg 25 Oct 2010
    IN006 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 75mg 21 Sep 2009
    IN011 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 75mg 13 Jun 2014
    IN016 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 75mg 21 Dec 2016
    RH025 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 0.150mg/0.030mg + 0mg 29 Sep 2010
    RH049 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mcg 08 Apr 2014
    RH044 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mg 21 Oct 2013
    RH038 Ethinylestradiol/Levonorgestrel + Ferrous Fumarate Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Ethinylestradiol/Levonorgestrel Tablet + Placebo (Ferrous Fumarate Tablet) 30mcg/150mcg + 75mg 11 Mar 2014
    RH030 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.150mg + 0mg 22 Dec 2011
    RH041 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH042 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablets + Placebo Tablets 0.03mg/0.15mg + 0mg 26 Aug 2013
    EMA Art 58 H-W-2319-3 Artesunate/Pyronaridine (phosphate) Malaria Shin Poong Pharmaceutical Co Ltd, 748-31 Yoksam-Dong, Gangnam-Gu, Seoul, 135-925, Republic of Korea Granules for Oral suspension 20mg/60mg
    TB156 Para-aminosalicylate (sodium) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Granules, Gastro-resistant 60g/100g 14 Dec 2009
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    RH028 Levonorgestrel Reproductive Health Shanghai Dahua Pharmaceutical Co Ltd, 3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai, China (People's Republic of) Implant 75mg per rod (150mg in total) 30 Jun 2017
    HA705 (a) Amphotericin B HIV/AIDS Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Powder for concentration for dispersion for infusion 50mg 19 Jun 2018
    ANDA 077774 USFDA 2 Stavudine HIV/AIDS Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, India Powder for Oral solution 1mg/ml
    TB229 (a) Para-aminosalicylate (sodium) Tuberculosis OlainFarm JSC, 5 Rupnicu Street, Olaine, 2114, Latvia Powder for Oral solution 4g 22 Mar 2011
    IN003 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Powder for Oral suspension 12mg/mL 21 Sep 2009
    TB211 Capreomycin (sulfate) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 10 May 2016
    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
    TB214 Streptomycin (sulfate) - Sterile Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 16 May 2019
    TB261 Capreomycin (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 1000mg 06 Oct 2014
    HA479 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 1000mg 16 May 2014
    HA622 Ceftriaxone (sodium) HIV/AIDS Shenzhen Zhijun Pharmaceutical Co Ltd, Workshop I Line III, Hi-Tech Zone, Guanlan, Baoan Area, Shenzhen, Guangdong, China (People's Republic of) Powder for solution for injection 1g 15 Aug 2016
    HA692 (a) Ceftriaxone (sodium) HIV/AIDS Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom of Great Britain and Northern Ireland Powder for solution for injection 1g 22 Feb 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
    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
    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
    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
    HA602 (a) Aciclovir HIV/AIDS Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece Powder for solution for injection 250mg/vial 08 Jan 2014
    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
    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
    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
    HA480 Ceftriaxone HIV/AIDS Egyptian International Pharmaceutical Industries Company(EIPICO), Cephalosporin Block, PO Box 149, Industrial Area B1, 10th of Ramadan City, Egypt Powder for solution for injection 500mg 16 May 2014
    HA515 Ganciclovir (sodium) HIV/AIDS Hainan Poly Pharma Co Ltd, Guilinyang Economic Development Area, Haikou, Hainan, China (People's Republic of) Powder for solution for injection 500mg 20 Dec 2012
    IN007 (a) Zanamivir Influenza Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, United Kingdom of Great Britain and Northern Ireland Powder, for Inhalation 5mg 22 Sep 2009
    MA135 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Powder, solvent and diluent for solution for injection 60mg + 5%w/v + 0.9%w/v 18 Dec 2018
    MA116 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 12.5mg/250mg + 76.5mg 21 Aug 2018
    MA117 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 25mg/500mg + 153mg 21 Aug 2018
    MA098 Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Pyrimethamine/Sulfadoxine Tablets + Amodiaquine (hydrochloride) Film coated Tablets 25mg/500mg + 150mg 20 Oct 2014
    MA066 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Pyrimethamine/Suphadoxine Tablet + Artesunate Tablet 25mg/500mg + 50mg 24 May 2012
    RH017 (a) Levonorgestrel Reproductive Health Bayer Pharma AG, Müllerstraße 178, Berlin, 13353, Germany Rod 75mg 23 Sep 2009
    CSVMedicines/Finished Pharmaceutical Products