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Drugs

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Historical Information on Isotretinoin (marketed as Accutane)

Many of these items are out-of-date.
For current information on Accutane (isotretinoin), click on Isotretinoin (marketed as Accutane) Capsule Information

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

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Related Information

Isotretinoin (marketed as Accutane) Capsule Information
Current Information
iPLEDGE March 2006 Update
3/22/2006
iPLEDGE Program Frequently Asked Questions As of July 21, 2006 (PDF - 68KB)
These FAQs have been provided by Covance, Inc., contractor for the sponsors of isotretinoin. (updated 8/15/2006)
Accutane (isotretinoin) Questions and Answers
11/23/2004
Accutane - Medication Guide 5/2002
Accutane - FDA Labeling Supplement Approval Letter
2/21/2002
Accutane - Advisory Committee Meeting Transcripts

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Contact FDA

1-800-332-1088

1-800-FDA-0178 Fax

Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857

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