FDA Approves Imipramine Hydrochloride (ANDA088292)

The U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) number ANDA088292 for imipramine hydrochloride tablets. The product, marketed under the brand name Imipramine Hydrochloride, is manufactured by Strides Pharma Science Limited. It is an oral prescription tablet available in a 10 mg strength. The FDA listing includes several National Drug Code (NDC) identifiers—product NDCs 64380-169, 64380-170, and 64380-171—and corresponding package codes such as 64380-169-01, 64380-169-02, 64380-170-01, 64380-170-02, 64380-171-01, and 64380-171-02. The product type is classified as a human prescription drug. Submission records show multiple manufacturing (CMC) submissions dating from 1983 to 1997 and labeling submissions up to 2005, all with an approved (AP) status.