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Labeler · US market

F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.

F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. is a US drug labeler with US FDA registrations covering 84 drug concepts (84 currently active) across 130 packages. It is currently the only active US supplier of 20 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: F.I.S. FABBRICA ITALIANA SINTETICI SPA

ACTIVE — US
openFDA · updated weekly
Labeler codes48087 · 52133
Active drugs84
Registrations128 active / 128
Packages130
Sole supplier of20 drugs

Portfolio84 drugs · US

Every drug concept this labeler has US registrations for, by package count.

DrugTypeNDCsPackagesStatus
Nitrofurantoin
powder
other77SUPPLYING
Oxcarbazepine
powder
other66SUPPLYING
Nitrofurantoin Monohydrate
powder
other55SUPPLYING
Efavirenz
powder
other44SUPPLYING
Olopatadine Hydrochloride
powder
other33SUPPLYING
Sitagliptin Phosphate
powder
other33SUPPLYING
Clotrimazole
powder
other33SUPPLYING
Tei-6720
powder
other33SUPPLYING
Clomiphene Citrate
powder
other22SUPPLYING
Furosemide
powder
other22SUPPLYING
Diazepam
powder
other22SUPPLYING
Clobazam
powder
other22SUPPLYING
Eletriptan Hydrobromide
powder
other22SUPPLYING
Procarbazine Hydrochloride
powder
other22SUPPLYING
Valbenazine Ditosylate
powder
other22SUPPLYING
Doravirine Sdi
powder
other22SUPPLYING
Chlordiazepoxide Hydrochloride
powder
other22SUPPLYING
Iivabradine
powder
other12SUPPLYING
Indomethacin
powder
other22SUPPLYING
Clonazepam
powder
other22SUPPLYING
Temazepam
powder
other22SUPPLYING
Sugammadex
powder
other22SUPPLYING
Carbamazepine
powder
other22SUPPLYING
Ranolazine
powder
other22SUPPLYING
Entacapone
powder
other22SUPPLYING
Nifedipine
powder
other22SUPPLYING
Progesterone
powder
other22SUPPLYING
Dorzolamide Hydrochloride
powder
other12SUPPLYING
Imatinib
powder
other11SUPPLYING
Trofinetide Hydrate
powder
other11SUPPLYING
Esomeprazole Magnesium Dihydrate
powder
other11SUPPLYING
Darifenacin Hydrobromide
powder
other11SUPPLYING
Sulindac
powder
other11SUPPLYING
Lorazepam
powder
other11SUPPLYING
Testosterone Undecanoate
powder
other11SUPPLYING
Testosterone Enanthate
powder
other11SUPPLYING
Nebivolol Hydrochloride
powder
other11SUPPLYING
Sofosbuvir
powder
other11SUPPLYING
Fosfomycin Trometamol
powder
other11SUPPLYING
Sumatriptan Succinate
powder
other11SUPPLYING

Showing 40 of 84 drugs by package count.