Last Updated: May 2, 2026

Details for New Drug Application (NDA): 216324

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NDA 216324 describes CUPRIC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, and Apotex Corp, and is included in three NDAs. Additional details are available on the CUPRIC SULFATE profile page.

The generic ingredient in CUPRIC SULFATE is cupric sulfate. Additional details are available on the cupric sulfate profile page.

Summary for 216324

Tradename:	CUPRIC SULFATE
Applicant:	Am Regent
Ingredient:	cupric sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.4MG COPPER/ML
Approval Date:	Dec 16, 2022	TE:		RLD:	No

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