FDA Corrects Notice on Withdrawal of 12 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that incorrectly announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants, including Breckenridge Pharmaceutical, Inc. (Breckenridge), and has now corrected the error regarding ANDA 077736 for Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopful.