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 applicant dossier part tentatively acceptable (QA phase remaining)

   
Product (INNs) Strength Dosage Form Quality Status Efficacy Status
Abacavir (sulfate)/Lamivudine 120mg/60mg Tablet, Dispersible
Yellow
Green
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Yellow
Green
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Red
Green
Albendazole 400mg Tablet
Red
Green
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Red
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Red
Yellow
Arginine/Sodium Bicarbonate + Artesunate 20mg/ml/8.4mg/ml + 60mg Powder for solution for injection
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Green
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Green
Artemether/Lumefantrine 40mg/240mg Tablet, Dispersible
Yellow
Green
Artemether/Lumefantrine 60mg/360mg Tablet, Dispersible
Yellow
Green
Artemether/Lumefantrine 80mg/480mg Tablet
Yellow
Yellow
Artemether/Lumefantrine 80mg/480mg Tablet
Red
Green
Artesunate + Sodium Bicarbonate + Sodium Chloride 60mg + 50mg/ml + 9mg/ml Powder and solvent for solution for injection
Red
Green
Artesunate + Sodium Bicarbonate + Sodium Chloride 60mg/vial + 50mg/ml + 9mg/ml Powder for solution for injection
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Clofazimine 100mg Capsules, soft
Red
Yellow
Clofazimine 100mg Tablet, Film-coated
Red
Green
Clofazimine 100mg Capsules, soft
Yellow
Green
Clofazimine 50mg Capsules, soft
Red
Yellow
Clofazimine 50mg Tablet, Film-coated
Red
Green
Cycloserine 250mg Capsules, hard
Yellow
Yellow
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Green
Daclatasvir (dihydrochloride)/Sofosbuvir 60mg/400mg Tablet, Film-coated
Yellow
Green
Darunavir 400mg Tablet, Film-coated
Red
Green
Darunavir 400mg Tablet, Film-coated
Red
Green
Darunavir 600mg Tablet, Film-coated
Red
Green
Darunavir 600mg Tablet, Film-coated
Red
Green
Darunavir 800mg Tablet, Film-coated
Red
Green
Darunavir 800mg Tablet, Film-coated
Red
Green
Darunavir (ethanolate)/Ritonavir 400mg/50mg Tablet, Film-coated
Yellow
Green
Darunavir/Ritonavir 400mg/50mg Tablet, Film-coated
Yellow
Yellow
Darunavir/Ritonavir 800mg/100mg Tablet, Film-coated
Yellow
Yellow
Delamanid 50mg Tablet, Film-coated
Yellow
Green
Desogestrel/Ethinylestradiol 0.15mg/0.03mg Tablet, Film-coated
Yellow
Green
Desogestrel/Ethinylestradiol + Placebo 0.15mg/0.03mg + 0mg Tablet, Film-coated
Yellow
Green
Dexamethasone phosphate 4mg/ml Solution for injection
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 30mg/240mg Tablet, Dispersible
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 60mg/480mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Green
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Green
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
Green
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
Yellow
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Green
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Yellow
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Yellow
Yellow
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Yellow
Yellow
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Estradiol valerate/Norethisterone enantate 5mg/50mg/mL Solution for injection
Yellow
Green
Estradiol valerate/Norethisterone enantate 5mg/ml/50mg/ml Solution for injection
Yellow
Green
Ethambutol hydrochloride 100mg Tablet, Dispersible
Red
Green
Ethambutol hydrochloride 50mg Tablet, Dispersible
Red
Green
Ethinylestradiol/Levonorgestrel 30mcg/150mcg Tablet, Sugar coated
Yellow
Yellow
Ethinylestradiol/Levonorgestrel + Ferrous Fumarate 0.03mg/0.15mg + 75mg Tablet, Film-coated
Red
Green
Flucytosine 250mg Tablet
Red
Yellow
Flucytosine 500mg Tablet
Red
Green
Isoniazid 100mg Tablet, Dispersible
Yellow
Yellow
Isoniazid 300mg Tablet
Yellow
Green
Isoniazid/Rifampicin 50mg/75mg Tablet, Dispersible
Yellow
Green
Isoniazid/Rifapentine 300mg/300mg Tablet, Film-coated
Red
Green
Ivermectin 3mg Tablet
Yellow
Yellow
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Yellow
Yellow
Ledipasvir/Sofosbuvir 90mg/400mg Tablet, Film-coated
Green
Green
Levofloxacin 250mg Tablet, Film-coated
Yellow
Yellow
Levofloxacin 250mg Tablet, Film-coated
Red
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Yellow
Levonorgestrel 0.75mg Tablet
Red
Red
Levonorgestrel 1.5mg Tablet
Red
Green
Lopinavir/Ritonavir 40mg/10mg Granules for Oral suspension
Green
Green
Magnesium sulfate 50%w/v Solution for injection
Red
Green
Medroxyprogesterone acetate 150mg/ml Suspension for injection
Yellow
Red
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Norethisterone 0.35mg Tablet
Yellow
Green
Oseltamivir 45mg Capsules, hard
Green
Green
Oseltamivir (phosphate) 30mg Capsules, hard
Green
Green
Oseltamivir (phosphate) 75mg Capsules, hard
Green
Green
Praziquantel 600mg Tablet, Film-coated
Red
Green
Protionamide 250mg Tablet, Film-coated
Green
Green
Pyridoxine hydrochloride 10mg Tablet
Yellow
Green
Pyridoxine hydrochloride 50mg Tablet
Yellow
Green
Pyrimethamine/Sulfadoxine 12.50mg/250mg Tablet, Dispersible
Yellow
Yellow
Pyrimethamine/Sulfadoxine 12.5mg/250mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 12.5mg/250mg Tablet, Dispersible
Red
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Red
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 75mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 25mg/500mg + 150mg Tablet, Dispersible
Yellow
Green
Ritonavir 25mg Tablet, Film-coated
Red
Red
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Sofosbuvir/Velpatasvir 400mg/100mg Tablet, Film-coated
Yellow
Green
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Zinc (sulfate) 10mg/5ml Syrup
Green
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Green
Green