General MedicationsSUBCUTANEOUSStandard
BREKIYA (AUTOINJECTOR)
DIHYDROERGOTAMINE MESYLATE
Standard Dose
1MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BREKIYA (AUTOINJECTOR) is listed in Drugs@FDA under application 215400 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIHYDROERGOTAMINE MESYLATE Form and strength SOLUTION;SUBCUTANEOUS - 1MG/ML Sponsor AMNEAL Submission history Latest submission status date: 2025-05-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview BREKIYA (AUTOINJECTOR) is listed in Drugs@FDA under application 215400 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIHYDROERGOTAMINE MESYLATE Form and strength SOLUTION;SUBCUTANEOUS - 1MG/ML Sponsor AMNEAL Submission history Latest submission status date: 2025-05-14 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.