Margot Williams filed this request with the Food and Drug Administration of the United States of America.
Tracking #




From: Margot Williams

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

NDA 20-553, the New Drug Application filed by Purdue Pharma L.P. on December 28, 1994 for OxyContin(oxycodone hydrochloride) controlled-released tablets, 10 mg, 20 mg and 40 mg. and supplemental amendments dated February 8, April 25, June 13, August 3, August 16, August 31, September 13, September 27, and November 29 1995. I am requesting the full application and attachments and exhibits.
I have searched the FDA site and its archives and have not found this document in the Public Reading Room.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.


Margot Williams

From: Food and Drug Administration

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From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.