Application 078825

Type
ANDA
Sponsor
MYLAN PHARMA

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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23920ORIG2009-11-12