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General MedicationsORALGeneric

XTRELUS

GUAIFENESIN; HYDROCODONE BITARTRATE

Standard Dose
400MG;5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview XTRELUS is listed in Drugs@FDA under application 208085 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE Form and strength TABLET;ORAL - 400MG;5MG Sponsor ECI PHARMS LLC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview XTRELUS is listed in Drugs@FDA under application 208085 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE Form and strength TABLET;ORAL - 400MG;5MG Sponsor ECI PHARMS LLC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.