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ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub

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ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only






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