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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218059

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NDA 218059 describes ZINC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, Apotex, Aspiro, Fresenius Kabi Usa, Gland, Nivagen Pharms Inc, Rk Pharma, Somerset Theraps Llc, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ZINC SULFATE profile page.

The generic ingredient in ZINC SULFATE is zinc sulfate. There are thirty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.

Summary for 218059

Tradename:	ZINC SULFATE
Applicant:	Apotex
Ingredient:	zinc sulfate
Patents:	0

Pharmacology for NDA: 218059

Physiological Effect	Decreased Copper Ion Absorption

Medical Subject Heading (MeSH) Categories for 218059

Astringents

Suppliers and Packaging for NDA: 218059

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	218059	ANDA	Apotex Corp	60505-6260	60505-6260-5	25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0)
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	218059	ANDA	Apotex Corp	60505-6261	60505-6261-5	25 VIAL in 1 CARTON (60505-6261-5) / 10 mL in 1 VIAL (60505-6261-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:	Jun 10, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date:	Oct 28, 2024	TE:	AP	RLD:	No

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