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Last Updated: November 22, 2024

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, Fresenius Kabi Usa, Gland Pharma Ltd, Nivagen Pharms Inc, Somerset Theraps Llc, and Zydus Pharms, and is included in eight NDAs. It is available from nine 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. Nine 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)

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

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