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2006P-0369
Cp 1
Volume 1
Citizen Petition
Tab 1 - Approved
Drug Products with Therapeutic Equivalence Evaluation ("Orange
Book") 26th edition listing for Aclovate (alclometasone dipropionate)
Cream 0.05%
Tab 2 - One-period,
randomized study comparing the relative potency of the proposed
Alclometasone Dipropionate Lotion, 0.05% formulation with that of
already approved formulations
Tab 3 - FDA-approved labeling for Aclovate (alclometasone dipropionate
cream) Cream 0.05% Published
Material
Tab 4 - Proposed
Labeling for Alclometasone Dipropionate Lotion 0.05%
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Page last updated
October 6, 2006
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