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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Aplisol September 23, 2008 Approval Letter

September 23, 2008

OUR STN: BL 103782/5068

JHP Pharmaceuticals, LLC
Attention: Carla English
One Upper Pond Road
Building D, 3rd Floor
Parsippany, NJ 07054

Dear Ms. English:

We have approved your request to supplement your biologics license application for Tuberculin, Purified Protein Derivative, to include revisions to the package insert.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.

We will include information contained in the above-referenced supplement in your biologics license applications file.

Sincerely yours,

/Wellington Sun, M.D./
Wellington Sun, M.D.
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeli


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