Document ID: FDA-2006-P-0283-0001
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-02-02T05:00Z

DEPARTMENT OF HEALTH & HUMAN SERVICES default		         		Public
Health Service

 ADVANCE \r360  ADVANCE \d3 	Food and Drug Administration

 ADVANCE \r360 	Rockville, MD  20857

February 1, 2006

Dr. Giovanni Parrinello

Macleod Pharmaceuticals Inc.

2600 Canton Court

Fort Collins, CO  80525

Dear Dr. Parrinello:

Your petition requesting the Food and Drug Administration to approve an
ANADA for Unibute Granules that contains 200 mg of phenylbutazone per g
of granules, was received by this office on 01/31/2006. It was assigned
docket number 2006P-0060/CP 1 and it was filed on 02/01/2006.  Please
refer to this docket number 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