ADVERTISING & LABELING ---------------------------------------------------------------------------------------------------------------------------------- 21 CFR PART 201--Labeling 21 CFR PART 202--Prescription Drug Advertising Information about Division of Drug Marketing and Communications - DDMAC DDMAC - FAQ DDMAC Communication and Events Laws, Regulations, Guidances, and Enforcement Actions Class Labeling Corticosteriods Consumer-Directed Advertisements-Q&A Consumer-Directed Broadcast Advertisements Q&A Product Name Placement, Size & Prominence in Ads Reminder Advertisements & Labeling - Q&A Safety Related Drug Labeling Change Summaries 1998

WARNING LETTERS ---------------------------------------------------------------------------------------------------------------------------------- Warning Letters and Notice of Violation Letters Warning Letters by Subject Most Recent Warning Letters Warning Letters by Issuing Office Warning Letters Indexed by Date Warning Letters by Company Warning Letters & Notice of Violation Letters to Pharmaceutical Companies

LABELING ---------------------------------------------------------------------------------------------------------------------------------- Class Labeling Corticosteriods E-Submissions Prescription Drug Advertising & Promotional Labeling Labeling Guidance Documents (CDER) Labeling Changes Related to Drug Safety Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals Labeling OTC Human Drug Products Updating Labeling in ANDAs Antiretroviral HIV Drug Approvals and Pediatric Labeling Information National Drug Code (NDC) Directory Guidance For Direct-To-Consumer Rx Drug Advertisements

OFFICE OF GENERIC DRUGS LABELING ---------------------------------------------------------------------------------------------------------------------------------- OGD-Labeling Review Branch OGD-Reference Listed Drug (RLD) Revising ANDA Labeling Following Revision of RLD Labeling OGD-Approved Labeling Supplements (NDA Number) OGD-Approved Labeling Supplements (Proprietary Name) OGD-Approved Labeling Supplements (Active Ingredient) OGD-Approved Labeling Supplements (Approval Date)