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General MedicationsINTRAVENOUSStandard

ATROPINE SULFATE

ATROPINE SULFATE

Standard Dose
1MG/ML (1MG/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 217345 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS - 1MG/ML (1MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2025-10-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview ATROPINE SULFATE is listed in Drugs@FDA under application 217345 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS - 1MG/ML (1MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2025-10-24 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.