General MedicationsORALGeneric

REZIRA

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose

5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 REZIRA is listed in Drugs@FDA under application 022442 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PERSION Submission history Latest submission status date: 2018-06-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview REZIRA is listed in Drugs@FDA under application 022442 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PERSION Submission history Latest submission status date: 2018-06-28 00:00:00.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.