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Plan B (0.75mg levonorgestrel)
Tablets Information
FDA today acknowledged that it has issued a “Not Approvable”
letter to the sponsor of an application to make the Plan B emergency
contraception product available without a prescription. In its
letter to the sponsor, FDA outlined the additional information that
would be required to gain approval to market Plan B
over-the-counter.
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Date created: May 7, 2004 |
