Document ID: FDA-2004-P-0215-0002
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-10-04T04:00Z

DEPARTMENT OF HEALTH & HUMAN SERVICES default		         		Public
Health Service

 ADVANCE \r360  ADVANCE \d3 	Food and Drug Administration

 ADVANCE \r360 	Rockville, MD  20857

  

October 4, 2004

Mr. Jerry S. Roth

Hill Dermaceuticals, Inc.

2650 South Mellonville Avenue

Sanford, Florida 32773-9361

Dear  Mr. Roth:

Your petition requesting the Food and Drug Administration to not approve
any generic equivalent version of the petitioner's proprietary drug
product DERMA-SMOOTHE/FS (fluocinolone acetonide 0.01% topical oil)
unless and until ANDA applicants comply with statutory requirements, 
was received by this office on 10/01/2004.  It was assigned docket
number 2004P-0448/CP 1 and it was filed 10/01/04.  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

x

x

x

x

Dear x:

Your petition requesting the Food and Drug Administration to
xxxxxxxxxxxxxxxxxxxxxxxxx, was received by this office on 08/12/2004. It
was assigned docket number 2004V-0364/VAR1 and it was filed on
08/12/2004.  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,

Jennie C. Butler, Director

Division of Dockets Management

Office of Management Programs

Office of Management