FDA.reportPublic FDA data

Application 075147

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET;ORAL20MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET;ORAL10MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42950ORIG1998-11-27
39458ORIG1998-11-27
30773ORIG1998-11-27