Public Health Service
Food and Drug Administration Rockville MD 20857
August Deborah L. Theres Ferndale Labs., Inc. 780 West Eight Mile Road Ferndale, Michigan 48220 Dear Ms. Theres:
15,
2001
Your petition requesting the Food and Drug Administration to approve an ANDA suitability for hydrocortisone acetate lotion, 2.5% was received by this office on 08/15/01. It was assigned docket number OlP-0355/CPl and it was filed on 08/15/01. Please refer to this docket number in future correspondence on this subject with the Agency. Please matter merits note that the in that it in of the petition. acceptance of no way reflects the petition an agency for filing is a procedural decision on the substantive
Sincerely,
Helen K. Harris Dockets Management
Branch