Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsRECTALStandard

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

Standard Dose
12.5MG
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 - 12.5MG 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 - 12.5MG 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.