General MedicationsINJECTIONStandard
OXYTOCIN
OXYTOCIN
Standard Dose
300USP UNITS/30ML (10USP UNITS/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OXYTOCIN is listed in Drugs@FDA under application 018248 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient OXYTOCIN Form and strength INJECTABLE;INJECTION - 300USP UNITS/30ML (10USP UNITS/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2022-09-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview OXYTOCIN is listed in Drugs@FDA under application 018248 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OXYTOCIN Form and strength INJECTABLE;INJECTION - 300USP UNITS/30ML (10USP UNITS/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2022-09-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.