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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

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Since the 25th edition, the Annual Edition and monthly Cumulative Supplements have been published in electronic Portable Document Format (PDF).

The PDF annual and cumulative supplements duplicate previous paper formats. Over time, there will be an archive page of Annual Editions and each year's December Cumulative Supplement that will provide a history of approved drug products' approvals and changes.

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