Drug Export; Vitinoin (Tretinoin) Gel 0.025% and Vitinoin (Tretinoin) Cream 0.025%, 0.05%, 0.1%

Samenvatting

The Food and Drug Administration (FDA) is announcing that Penederm, Inc., has filed an addendum application requesting approval for the export of the human drug Vitinoin (tretinoin) Gel 0.025% and Vitinoin (tretinoin) Cream 0.025%, 0.05%, 0.1% to Canada. The FDA had received a previous application on March 7, 1994, from Penederm, Inc., which was published in the Federal Register of May 13, 1994, requesting approval for the export of the human drug Acticin (tretinoin) Gel 0.025% to Canada. This notice announces a product name change, the addition of the cream formulations and a change in the manufacturing site.