FPPs Under Assessment

This section of the website provides information on the status of FPP dossiers that are currently under assessment (i.e. not yet prequalified).

It includes:

  • only those dossiers that have been screened and accepted for assessment
  • several FPPs with the same international proprietary name (INN), strength, unit and dosage form, that have are produced and have been submitted for evaluation by different manufacturers.

It does not include:

  • prequalified FPPs; once an FPP has been prequalified it is included in the WHO List of Prequalified Medicinal Products.

assessment in progress        additional data to be provided by the manufacturer dossier part acceptable

   
Product (INNs) Strength Dosage Form Quality Status Efficacy Status
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Yellow
Green
Albendazole 400mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 135mg/50mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 135mg/50mg Tablet
Yellow
Yellow
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Yellow
Green
Artemether 80mg Solution for injection
Yellow
Green
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Green
Artemether/Lumefantrine 40mg/240mg Tablet
Yellow
Green
Artemether/Lumefantrine 80mg/480mg Tablet
Yellow
Green
Artemether/Lumefantrine 80mg/480mg Tablet, Film-coated
Yellow
Green
Artesunate + Sodium Bicarbonate + Sodium Chloride 60mg + 5%w/v + 0.9%w/v Powder and solvent for solution for injection
Green
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Red
Red
Ciprofloxacin (hydrochloride) 250mg Tablet, Film-coated
Red
Red
Clofazimine 100mg Capsules, soft
Red
Red
Clofazimine 100mg Tablet, Film-coated
Yellow
Green
Clofazimine 50mg Tablet, Film-coated
Yellow
Yellow
Cycloserine 250mg Capsules, hard
Yellow
Green
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Yellow
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Yellow
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Yellow
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) + Sofosbuvir 60mg + 400mg Tablet, Film-coated
Yellow
Yellow
Darunavir 400mg Tablet, Film-coated
Red
Yellow
Darunavir 600mg Tablet, Film-coated
Red
Yellow
Darunavir 800mg Tablet, Film-coated
Red
Green
Darunavir 800mg Tablet, Film-coated
Green
Green
Darunavir (ethanolate) 600mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate) 800mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate)/Ritonavir 400mg/50mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate)/Ritonavir 400mg/50mg Tablet, Film-coated
Red
Yellow
Desogestrel/Ethinylestradiol 0.15mg/0.03mg Tablet, Film-coated
Yellow
Green
Desogestrel/Ethinylestradiol + Placebo 0.15mg/0.03mg + 0mg Tablet, Film-coated
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 20mg/160mg Tablet, Dispersible
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 40mg/320mg Tablet, Dispersible
Yellow
Yellow
Dihydroartemisinin/Piperaquine (phosphate) 40mg/320mg Tablet, Film-coated
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 80mg/640mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Yellow
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Yellow
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil (fumarate) 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Yellow
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Red
Red
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Red
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Efavirenz 600mg Tablet, Film-coated
Red
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Red
Red
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Yellow
Yellow
Emtricitabine/Tenofovir disoproxil fumarate 200mg/300mg Tablet, Film-coated
Yellow
Yellow
Emtricitabine/Tenofovir disoproxil fumarate 200mg/300mg Tablet, Film-coated
Red
Yellow
Estradiol valerate/Norethisterone enantate 5mg/50mg/mL Solution for injection
Yellow
Green
Estradiol valerate/Norethisterone enantate 5mg/ml/50mg/ml Solution for injection
Red
Red
Ethambutol (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Ethinylestradiol/Levonorgestrel 0.03mg/0.15mg Tablet, Film-coated
Yellow
Green
Ethinylestradiol/Levonorgestrel + Placebo 0.03mg/0.15mg + 0mg Co-Pack
Yellow
Green
Ethionamide 125mg Tablet, Dispersible
Green
Green
Isoniazid 100mg Tablet, Dispersible
Yellow
Green
Isoniazid 100mg Tablet, Dispersible
Yellow
Yellow
Isoniazid 50mg Tablet, Dispersible
Yellow
Green
Isoniazid/Rifampicin 150mg/300mg Tablet, Film-coated
Yellow
Green
Isoniazid/Rifampicin 50mg/75mg Tablet
Yellow
Yellow
Isoniazid/Rifampicin 75mg/150mg Tablet, Film-coated
Yellow
Yellow
Kanamycin (sulfate) 1g Solution for injection
Green
Green
Kanamycin (sulfate) 1g/3ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 1g/3ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 500mg Solution for injection
Green
Green
Kanamycin (sulfate) 500mg/2ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 500mg/2ml Solution for injection
Yellow
Green
Lamivudine 300mg Tablet, Film-coated
Yellow
Green
Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg Tablet, Film-coated
Yellow
Green
Lamivudine/Tenofovir disoproxil fumarate 300mg/300mg Tablet, Film-coated
Yellow
Green
Lamivudine/Tenofovir disoproxil fumarate 300mg/300mg Tablet, Film-coated
Yellow
Yellow
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Green
Green
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Yellow
Green
Ledipasvir/Sofosbuvir 90mg/400mg Tablet, Film-coated
Yellow
Green
Ledipasvir/Sofosbuvir 90mg/400mg Tablet, Film-coated
Yellow
Green
Ledipasvir/Sofosbuvir 90mg/400mg Tablet, Film-coated
Yellow
Green
Levofloxacin 100mg Tablet, Dispersible
Yellow
Green
Levofloxacin 250mg Tablet, Film-coated
Yellow
Green
Levofloxacin 250mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Yellow
Levofloxacin 750mg Tablet, Film-coated
Yellow
Green
Levofloxacin 750mg Tablet, Film-coated
Yellow
Green
Levonorgestrel 0.75mg Tablet
Yellow
Yellow
Levonorgestrel 1.5mg Tablet
Yellow
Green
Linezolid 600mg Tablet, Film-coated
Yellow
Green
Linezolid 600mg Tablet, Film-coated
Yellow
Green
Linezolid 600mg Tablet, Film-coated
Yellow
Green
Lopinavir/Ritonavir 40mg/10mg Granules for Oral suspension
Yellow
Green
Magnesium sulfate 500mg/ml (10ml) Solution for injection
Yellow
Red
Mebendazole 500mg Tablets, Chewable
Yellow
Yellow
Medroxyprogesterone acetate 150mg Suspension for injection
Yellow
Green
Medroxyprogesterone acetate 150mg/ml Suspension for injection
Yellow
Yellow
Medroxyprogesterone acetate 150mg/ml Suspension for injection
Red
Yellow
Moxifloxacin (hydrochloride) 100mg Tablet, Dispersible
Green
Green
Moxifloxacin (hydrochloride) 100mg Tablet, Dispersible
Yellow
Green
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Green
Yellow
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Norethisterone 0.35mg Tablet
Red
Red
Oxytocin 10IU/mL Solution for injection
Yellow
Yellow
Oxytocin 10IU/ml Solution for injection
Yellow
Green
Para-aminosalicylate (sodium) 5.52g Powder for Oral solution
Red
Red
Protionamide 250mg Tablet, Film-coated
Yellow
Yellow
Pyrimethamine/Sulfadoxine 12.5mg/250mg Tablet, Dispersible
Red
Red
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Red
Red
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet
Green
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 75mg Tablet, Dispersible
Red
Red
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 75mg Co-Pack
Green
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 25mg/500mg + 150mg Tablet, Dispersible
Red
Red
Pyrimethamine/Sulfadoxine + Artesunate 25mg/500mg + 100mg Co-Pack
Yellow
Green
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Sofosbuvir 400mg Tablet, Film-coated
Green
Green
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Streptomycin (sulfate) - Sterile 1000mg Powder for solution for injection
Yellow
Green
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Zinc (as sulfate) 20mg Tablet, Dispersible
Yellow
Green
Zinc (sulfate) 10mg/5ml Syrup
Yellow
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Yellow
Green