Details for New Drug Application (NDA): 218814

NDA 218814 describes SUGAMMADEX SODIUM, which is a drug marketed by Aspiro, B Braun Medical, Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Lupin, Mankind Pharma, MSN, Mylan, Qilu Pharm Hainan, Sandoz, Steriscience, Sun Pharm Inds Inc, Tamarang, Teva Pharms Usa Inc, Zenara, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-two suppliers. Additional details are available on the SUGAMMADEX SODIUM profile page.

The generic ingredient in SUGAMMADEX SODIUM is sugammadex sodium. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

Summary for 218814

Tradename:	SUGAMMADEX SODIUM
Applicant:	Steriscience
Ingredient:	sugammadex sodium
Patents:	0

Pharmacology for NDA: 218814

Suppliers and Packaging for NDA: 218814

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	218814	ANDA	Par Health USA, LLC	42023-830	42023-830-10	10 SYRINGE in 1 CARTON (42023-830-10) / 2 mL in 1 SYRINGE
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	218814	ANDA	Par Health USA, LLC	42023-935	42023-935-10	10 SYRINGE in 1 CARTON (42023-935-10) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date:	Jul 28, 2026	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:	Jul 28, 2026	TE:	AP	RLD:	No

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