Document ID: FDA-2007-P-0065-0004
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-09T04:00Z

DEPARTMENT OF HEALTH & HUMAN SERVICES			Public Health Service

																			Food and Drug Administration

		Rockville MD 20857



May 9, 2007

Peter R. Mathers

Kleinfeld, Kaplan and Becker, LLP

1140 Nineteenth Street, N.W.

Washington, DC  20036-6606

Dear Mr. Mathers:

Your petition submitted on behalf of Perdue Pharma L.P. requesting the
Food and Drug Administration to refuse to stay the potential grant of
effective approval of the new drug application for CIP-TRAMADOL ER, was
received by this office on 05/02/2007.  It was assigned docket numbers
2007P-0093/PSA 1 and 2007P-0127/PSA 1 respectively, and it was filed on
05/02/2007. Please refer to these docket numbers in future
correspondence on this subject with the Agency.

Please note that the acceptance of the petition for filing is a
procedural matter in that it in no way reflects an agency decision on
the substantive merits of the petition.

Sincerely,

Lyle D. Jaffe

Division of Dockets Management

Office of Management Programs

Office of Management

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