The requirements of the line extension provision of the final rule are effective as of the effective date of the final rule (April 1, 2016).
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Date
Sub Topic
FAQ ID
94836
FAQ Page
FAQ Question
Can you confirm that manufacturers of extended release formulations will have to calculate the alternative line extension AMP starting April 1, 2016, since extended release formulations are specifically mentioned in the statutory language that established the alternative line extension formula?