General MedicationsORALGeneric

PROMETH W/ DEXTROMETHORPHAN

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Standard Dose

15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Marketing status: Discontinued

Summary

Approval overview PROMETH W/ DEXTROMETHORPHAN is listed in Drugs@FDA under application 088762 (ANDA).

Marketing status: Discontinued Active ingredient DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor G AND W LABS INC Submission history Latest submission status date: 2015-11-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview PROMETH W/ DEXTROMETHORPHAN is listed in Drugs@FDA under application 088762 (ANDA). Marketing status: Discontinued Active ingredient DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor G AND W LABS INC Submission history Latest submission status date: 2015-11-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued

Interaction Notes

No interaction notes stored yet.