Application 078658

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSIGLITAZONE MALEATEROSIGLITAZONE MALEATETABLET; ORAL2MGNoNo
002ROSIGLITAZONE MALEATEROSIGLITAZONE MALEATETABLET; ORAL4MGNoNo
003ROSIGLITAZONE MALEATEROSIGLITAZONE MALEATETABLET; ORAL8MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.