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General MedicationsINTRAMUSCULAR, INTRAVENOUSStandard

MORPHINE SULFATE

MORPHINE SULFATE

Standard Dose
10MG/ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MORPHINE SULFATE is listed in Drugs@FDA under application 204223 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MORPHINE SULFATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10MG/ML (10MG/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview MORPHINE SULFATE is listed in Drugs@FDA under application 204223 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MORPHINE SULFATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10MG/ML (10MG/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.