General MedicationsINJECTIONStandard
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
Standard Dose
50MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DIPHENHYDRAMINE HYDROCHLORIDE is listed in Drugs@FDA under application 219845 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIPHENHYDRAMINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 50MG/ML Sponsor MICRO LABS Submission history Latest submission status date: 2025-08-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIPHENHYDRAMINE HYDROCHLORIDE is listed in Drugs@FDA under application 219845 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIPHENHYDRAMINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 50MG/ML Sponsor MICRO LABS Submission history Latest submission status date: 2025-08-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.