Abstract
Observations relating to labeling policy and requirements for post-1962 ANDAs submitted as a result of the Drug Price Competition and Patent Term Restoration Act of 1984 are presented. Topics covered include the issue of listed drug ex clusivity protection, and pharmacokinetic information. Also, a series of topics which the Division of Generic Drugs (DGD) believes require more consideration by applicants is discussed. These topics include: protect from light, unit-dose labeling, inactive ingredient labeling for oral dosage form prescription drugs, theophylline, physician samples, and the NDA rewrite. The presentation en courages applicants to work closely with the DGD labeling staff when planning labeling revision.
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