What is current pader reporting interval for this product

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Reference no: EM133317296

Assignment:

Question: In regards to ANDA 205510

What product is this and who is the applicant? (Be sure to include strengths)
In accordance with 21 CFR 314.80(c)(2) what is the current PADER reporting interval for this product?
What is the reporting period of the FIRST EVER QUARTERLY PADER for this product?
How many days from the close of the reporting period must the FIRST EVER QUARTERLY PADER be submitted to the FDA?

Reference no: EM133317296

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