FDA.reportPublic FDA data

Application 075041

Type
ANDA
Sponsor
ALKERMES GAINESVILLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22404ORIG1998-09-22
18381ORIG1998-09-22
8496ORIG1998-09-22