Details for New Drug Application (NDA): 215260

NDA 215260 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 215260

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

Pharmacology for NDA: 215260

Suppliers and Packaging for NDA: 215260

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	215260	ANDA	Solupharm Pharmazeutische Erzeugnisse GmbH	55579-892	55579-892-10	10 VIAL, SINGLE-DOSE in 1 CARTON (55579-892-10) / 2 mL in 1 VIAL, SINGLE-DOSE (55579-892-01)
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	215260	ANDA	Somerset Therapeutics, LLC	70069-892	70069-892-10	10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10) / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01)

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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