Details for New Drug Application (NDA): 209377

NDA 209377 describes ZINC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, and Zydus Pharms, and is included in five NDAs. It is available from six 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. Six suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.

Summary for 209377

Tradename:	ZINC SULFATE
Applicant:	Am Regent
Ingredient:	zinc sulfate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 209377

Physiological Effect

Decreased Copper Ion Absorption

Medical Subject Heading (MeSH) Categories for 209377

Astringents

Suppliers and Packaging for NDA: 209377

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	209377	NDA	American Regent, Inc.	0517-6101	0517-6101-25	25 VIAL in 1 TRAY (0517-6101-25) / 10 mL in 1 VIAL (0517-6101-01)
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	209377	NDA	American Regent, Inc.	0517-6103	0517-6103-25	25 VIAL in 1 TRAY (0517-6103-25) / 10 mL in 1 VIAL (0517-6103-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date:	Jul 18, 2019	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:	Jul 18, 2019	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date:	Apr 15, 2020	TE:	AP	RLD:	Yes

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