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Orathecin Approval Status

FDA Approved: No
Brand name: Orathecin
Generic name: rubitecan
Dosage form: Capsules
Company: SuperGen Inc.
Treatment for: Pancreatic Cancer

Development Status and FDA Approval Process for Orathecin

DateArticle
Jan  3, 2005SuperGen Announces Withdrawal of Orathecin NDA
Nov 29, 2004SuperGen Announces 90 Day Extension of FDA Review Date for Orathecin New Drug Application
Mar 26, 2004SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing
Mar 26, 2004SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing
Jan 28, 2004SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer

Further information

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