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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215400

BREKIYA (AUTOINJECTOR) (DIHYDROERGOTAMINE MESYLATE)
1MG/ML
Marketing Status: Prescription
Active Ingredient: DIHYDROERGOTAMINE MESYLATE
Proprietary Name: BREKIYA (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215400
Product Number: 001
Approval Date: May 14, 2025
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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