Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208085
Company: ECI PHARMS LLC
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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208085s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208085Orig1s002ltr.pdf | |
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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208085s002lbl.pdf | |
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 |