General MedicationsRECTALStandard
PROMETHEGAN
PROMETHAZINE HYDROCHLORIDE
Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PROMETHEGAN is listed in Drugs@FDA under application 087165 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PROMETHAZINE HYDROCHLORIDE Form and strength SUPPOSITORY;RECTAL - 50MG Sponsor COSETTE Submission history Latest submission status date: 2016-09-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview PROMETHEGAN is listed in Drugs@FDA under application 087165 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PROMETHAZINE HYDROCHLORIDE Form and strength SUPPOSITORY;RECTAL - 50MG Sponsor COSETTE Submission history Latest submission status date: 2016-09-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.