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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022225

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BRIDION (SUGAMMADEX SODIUM)
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: SUGAMMADEX SODIUM
Proprietary Name: BRIDION
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N022225
Product Number: 002
Approval Date: Dec 15, 2015
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIDION (SUGAMMADEX SODIUM)
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: SUGAMMADEX SODIUM
Proprietary Name: BRIDION
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022225
Product Number: 001
Approval Date: Dec 15, 2015
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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