FDA Approves ANDA077968 for Alprazolam Extended‑Release Tablets (IMPAX Labs)

The U.S. Food and Drug Administration granted approval for application number ANDA077968 on May 24, 2007. The submission was an original (ORIG) filing submitted by IMPAX Labs. The approved ANDA covers four oral, extended‑release alprazolam tablet products (product numbers 001‑004). Each product contains alprazolam as the sole active ingredient at strengths of 0.5 mg, 1 mg, 2 mg, and 3 mg respectively. None of the products are designated as reference drugs, and all are listed with a marketing status of "Discontinued." No reference standard is associated with these products. These details reflect the current regulatory status of the listed alprazolam extended‑release tablets as recorded by the FDA.