Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208085
Company: ECI PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XTRELUS GUAIFENESIN; HYDROCODONE BITARTRATE 400MG;5MG TABLET;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
04/25/2018 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208085Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208085Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2018 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208085Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s001lbl.pdf
10/31/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s001lbl.pdf
04/25/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s000lbl.pdf

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