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Office of Generic Drugs

 

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Metro Park North II

7500 Standish Place

Rockville, MD 20855

Office of Generic Drugs

Division of Labeling and Program Support

Phone - (301) 827-5846

Fax - (301) 443-3847

Mail Code - HFD-613

 


Team I

Team Leader - John F. Grace

Angela Payne

Ruby Wu

Beverly Weitzman

Debra Catterson

Jim Barlow

Team II

Team Leader - Lillie Golson

Adolph Vezza

Michelle Dillahunt

Jacqueline Council

Chan Park

Koung Lee


 

Welcome to the Labeling Review Branch's Homepage

The purpose of this page is to provide information on approved labeling  for Reference Listed Drug (RLD) products.

 

 

 Keep ANDA Labeling Current

Subscribe to daily or weekly updates , 

or

Visit the "What's New" page.

or

Monitor this page often. It is updated regularly. The Table below contains links to Monthly Lists of RLD labeling and efficacy supplements approved for a specific month. 

 

The Easiest and Fastest Way to Keep ANDA Labeling Current is to Subscribe to Daily or Weekly Updates

These E-mail lists are available for you to subscribe, free of charge. The links below will allow you to join or leave each list.

CDERNEW - One daily email containing new updates to our website.

CDERWEEK - One weekly email containing new updates to our website 

 

QUICK LINKS

December 2002 RLD Labeling New!

Guidance for Industry   Revising ANDA Labeling Following Revision of the RLD Labeling

New Drug Approvals Updated Daily


If the monthly list does not contain a link to the approved labeling for a specific product, a written or fax request should be made to CDER's Freedom of Information Office (see Guidance).

To view a MONTHLY LIST - Click on a month
2002 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2002
2001

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct Nov Dec 2001
2000 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2000

1999

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

1999

1998

None available prior to June 1998

Jun

Jul

Aug

Sep

Oct

Nov

Dec

1998

 

Other Resources

New Drugs Approved for Cancer Indications - A current listing of new cancer drugs.

FDA Drug Approvals List. Chronological listing of all drugs (NDAs, ANDAs. NDA labeling supplements, efficacy supplements) approved since September 1996.

Over-the-Counter (OTC) Home Page. Contains info on labeling requirements for OTC drugs.

Labeling Changes Related to Drug Safety. Part of MedWatch. Contains summaries of safety related changes to labeling.

Consumer Drug Info Page. Contains links to labeling for many brand name products.

Labeling OTC Human Drug Products - Updating Labeling in ANDAs.  Draft OTC guidance for OTC products.

How FDA Reviews Drug Names. An "FDA Safety Page" from Drug Topics describing the review of a proprietary name.

The "Best Pharmaceuticals for Children Act. Section 11 allows for approval of an ANDA when pediatric indication is protected by patent or exclusivity

Requirements for Submission of Labeling to Human Prescription Drugs and Biologics in Electronic Format. A proposed rule to amend FDA regulations governing the format in which certain labeling is required to be submitted for review with NDAs, ANDAs, supplements, and annual reports.

Name Differentiation Project. OGD requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order to minimize medication errors resulting from look-alike confusion.

         

 

 

FDA/Center for Drug Evaluation and Research
Last Updated: Wednesday, May 21, 2003
Originator: OGD/DLPS/LRB
HTML by  JFG