General MedicationsORALGeneric

TUSSIONEX PENNKINETIC

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Standard Dose

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview TUSSIONEX PENNKINETIC is listed in Drugs@FDA under application 019111 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor UCB INC Submission history Latest submission status date: 2018-06-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview TUSSIONEX PENNKINETIC is listed in Drugs@FDA under application 019111 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor UCB INC Submission history Latest submission status date: 2018-06-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.