April 2015


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NAYNA PATEL <[log in to unmask]>
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 16 Apr 2015 01:49:12 +0000
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Dear all,

For the ANDA product, did anyone use a bracketing and/or matrixing approach for the stability study ? Using the product information listed below, I have the following questions for the group:

Product Category: Ointment /Cream
Packaged in: 15gm, 30gm, 45gm and 60gm Tubes
Number of Batches: Three
Orientation: Upright and Horizontal


1. Did you use only the matrixing approach for the ANDA filing? If yes, was it accepted by the FDA?
2. Did you use only the bracketing approach for the ANDA filing ?  If yes, was it accepted by the FDA ?
3. Did you use both the bracketing and matrixing approach for the ANDA filing ? If yes, was it accepted by the FDA?

Thank you in advance for your time.

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