Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214337

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SUGAMMADEX SODIUM (SUGAMMADEX SODIUM)
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: SUGAMMADEX SODIUM
Proprietary Name: SUGAMMADEX SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214337
Product Number: 001
Approval Date: Jun 9, 2023
Applicant Holder Full Name: ASPIRO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SUGAMMADEX SODIUM (SUGAMMADEX SODIUM)
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: SUGAMMADEX SODIUM
Proprietary Name: SUGAMMADEX SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214337
Product Number: 002
Approval Date: Jun 9, 2023
Applicant Holder Full Name: ASPIRO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information