General MedicationsORALGeneric

HYCOFENIX

GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose

200MG/5ML;2.5MG/5ML;30MG/5ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview HYCOFENIX is listed in Drugs@FDA under application 022279 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML Sponsor CHARTWELL RX Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYCOFENIX is listed in Drugs@FDA under application 022279 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML Sponsor CHARTWELL RX 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.