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

Questions:

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.
Nayna






This message contains confidential information, intended only for the person(s) named above, which may also be privileged. Any use, distribution, copying or disclosure by any other person is strictly prohibited. In such case, you should delete this message and kindly notify the sender via reply e-mail. Please advise immediately if you or your employer does not consent to Internet e-mail for messages of this kind.

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.