Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205579

RYANODEX (DANTROLENE SODIUM)
250MG/VIAL
Marketing Status: Prescription
Active Ingredient: DANTROLENE SODIUM
Proprietary Name: RYANODEX
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAVENOUS
Strength: 250MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205579
Product Number: 001
Approval Date: Jul 22, 2014
Applicant Holder Full Name: EAGLE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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