General MedicationsINTRAVENOUSStandard
ATROPINE SULFATE
ATROPINE SULFATE
Standard Dose
0.25MG/5ML (0.05MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ATROPINE SULFATE is listed in Drugs@FDA under application 212868 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML) Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2026-03-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview ATROPINE SULFATE is listed in Drugs@FDA under application 212868 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML) Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2026-03-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.