General MedicationsRECTALStandard

PROMETHAZINE HYDROCHLORIDE

Standard Dose

25MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PROMETHAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 216446 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PROMETHAZINE HYDROCHLORIDE Form and strength SUPPOSITORY;RECTAL - 25MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2022-11-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview PROMETHAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 216446 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PROMETHAZINE HYDROCHLORIDE Form and strength SUPPOSITORY;RECTAL - 25MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2022-11-02 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.