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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022411
Company: ANGELINI PHARMA

Medication Guide

Summary Review

Products on NDA 022411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLEPTRO	TRAZODONE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
OLEPTRO	TRAZODONE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022411lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022411s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411_oleptro_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-8	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022411s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022411Orig1s008ltr.pdf
11/13/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022411s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022411Orig1s007ltr.pdf
05/11/2011	SUPPL-6	REMS-Modified		Label is not available on this site.
05/11/2011	SUPPL-5	REMS-Proposal		Label is not available on this site.
05/05/2011	SUPPL-4	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022411s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022411s004ltr.pdf

Labels for NDA 022411

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022411s008lbl.pdf
11/13/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022411s007lbl.pdf
05/05/2011	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022411s004lbl.pdf
02/02/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022411lbl.pdf

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