Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022411
Company: ANGELINI PHARMA
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OLEPTRO TRAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
OLEPTRO TRAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
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
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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