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Forest’s Esgic tablets

Executive Summary

FDA is withdrawing approval of the ANDA at the request of the company after the agency raised questions about the reliability of the data and information submitted in support of the application, a Nov. 2 Federal Register states. Forest conducted its own review of the data and believes the information to be reliable. However, confirmation of reliability could not be assured to FDA's satisfaction. Forest says the company has an alternative source of the product under a separate ANDA. The ANDA for Esgic tablets (acetaminophen 325 mg, butalbital 50 mg and caffeine 40 mg) was submitted in February 1987 and approved in December 1988.
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PS023553

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