FDA.reportPublic FDA data

Application 075390

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENTABLET, DELAYED RELEASE;ORAL375MGNoNo
002NAPROXENNAPROXENTABLET, DELAYED RELEASE;ORAL500MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42987ORIG2001-04-19
39482ORIG2001-04-19
30870ORIG2001-04-19