General MedicationsSUBCUTANEOUSStandard
FRAGMIN
DALTEPARIN SODIUM
Standard Dose
7,500IU/0.3ML (25,000IU/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FRAGMIN is listed in Drugs@FDA under application 020287 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DALTEPARIN SODIUM Form and strength INJECTABLE;SUBCUTANEOUS - 7,500IU/0.3ML (25,000IU/ML) Sponsor PFIZER Submission history Latest submission status date: 2024-10-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview FRAGMIN is listed in Drugs@FDA under application 020287 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DALTEPARIN SODIUM Form and strength INJECTABLE;SUBCUTANEOUS - 7,500IU/0.3ML (25,000IU/ML) Sponsor PFIZER Submission history Latest submission status date: 2024-10-24 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.