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Inactive ingredients

Executive Summary

FDA is revoking its interim policy on inactive ingredients in parenteral ophthalmic, otic and topical generic drugs because the policy "no longer represents current agency thinking." The interim policy was issued as a memo by the Office of Generic Drugs in 1994. OGD is developing a draft guidance on inactive ingredients in ANDAs that will replace the interim policy ("The Pink Sheet" Nov. 30, 1998, p. 21)
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PS034094

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