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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010841
Company: RECORDATI RARE

Medication Guide

Products on NDA 010841

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEGANONE	ETHOTOIN	250MG	TABLET;ORAL	Discontinued	None	Yes	No
PEGANONE	ETHOTOIN	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010841

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	Labeling, REMS-Proposal	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.

Labels for NDA 010841

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