Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010841
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEGANONE ETHOTOIN 250MG TABLET;ORAL Prescription None Yes Yes
PEGANONE ETHOTOIN 500MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/1957 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2017 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/23/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/31/2011 SUPPL-23 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010841s023ltr.pdf
06/07/2010 SUPPL-22 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010841s022ltr.pdf
04/23/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010841s021ltr.pdf
02/02/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010841s020LTR.pdf
12/10/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf
09/26/2003 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf
11/13/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1983 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/04/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1982 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2010 SUPPL-22 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf
06/07/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf
04/23/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf
02/02/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf

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