Details for New Drug Application (NDA): 214337

NDA 214337 describes SUGAMMADEX SODIUM, which is a drug marketed by Aspiro, B Braun Medical, and Zydus Pharms, and is included in three NDAs. It is available from four suppliers. Additional details are available on the SUGAMMADEX SODIUM profile page.

The generic ingredient in SUGAMMADEX SODIUM is sugammadex sodium. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

Summary for 214337

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

Pharmacology for NDA: 214337

Suppliers and Packaging for NDA: 214337

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337	ANDA	Camber Pharmaceuticals, Inc.	31722-254	31722-254-10	10 VIAL, SINGLE-DOSE in 1 CARTON (31722-254-10) / 2 mL in 1 VIAL, SINGLE-DOSE
SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337	ANDA	Camber Pharmaceuticals, Inc.	31722-255	31722-255-10	10 VIAL, SINGLE-DOSE in 1 CARTON (31722-255-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date:	Jun 9, 2023	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:	Jun 9, 2023	TE:	AP	RLD:	No

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