FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website
Skip navigationFDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions
horizonal rule
Dockets Management

Back

2006P-0369
AMD 1
Volume 1

Amendment

Exhibit 1 - ANDA Suitability Petition for Alclometasone Dipropionate Lotion, 0.05%

Attachment 1 - Approved Drug Products with Therapeutic Equivalence Evaluation ("Orange Book") 26th edition listing for Aclovate (alclometasone dipropionate) Cream 0.05%

Attachment 2 - Clinical Study Report for Alclometasone Dipropionate Lotion, 0.05%

Attachment 3 - FDA-approved labeling for Aclovate (alclometasone dipropionate cream) 0.05%

Attachment 4 - Proposed labeling for Alclometasone Dipropionate Lotion, 0.05%

Top | Back

Page last updated January 9, 2007 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management