Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022442
Company: PERSION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REZIRA HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None Yes No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
06/08/2011 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022442s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442_rezira_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2018 SUPPL-10 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf
01/13/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022442s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf
06/28/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf
01/13/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022442s009lbl.pdf
06/08/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf

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