Application 078695

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSIGLITAZONE MALEATEROSIGLITAZONE MALEATETABLET; ORAL2MGNoNo

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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44392ORIG2009-11-12