FDA Approves ANDA087564 for Isosorbide Dinitrate Tablet

The U.S. Food and Drug Administration (FDA) has issued an approval (status AP) for application number ANDA087564 submitted by Sun Pharm Industries. The approved product is an oral tablet of Isosorbide Dinitrate, 30 mg strength, identified as product number 001. The product is listed with a marketing status of "Discontinued" and is not a reference drug. The submission history includes multiple supplemental (SUPPL) filings covering manufacturing (CMC) and labeling, with submission numbers ranging from 1 to 19 and approval dates from 1984 to 1998. No reference standard is indicated for this product.