FDA Corrects Notice on SoloPak Laboratories' Withdrawal of Drug Approval Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 21, 1999, regarding the withdrawal of approval of 1 new drug application (NDA) and 38 abbreviated new drug applications (ANDA's) submitted by SoloPak Laboratories, Inc. The FDA is now clarifying that the sponsor voluntarily removed the products from the market due to discrepancies in the submitted data.