Details for New Drug Application (NDA): 216145

NDA 216145 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 216145

Tradename:	ZINC SULFATE
Applicant:	Fresenius Kabi Usa
Ingredient:	zinc sulfate
Patents:	0

Pharmacology for NDA: 216145

Physiological Effect

Decreased Copper Ion Absorption

Medical Subject Heading (MeSH) Categories for 216145

Astringents

Suppliers and Packaging for NDA: 216145

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216145	ANDA	Fresenius Kabi USA, LLC	65219-401	65219-401-01	25 VIAL in 1 TRAY (65219-401-01) / 10 mL in 1 VIAL (65219-401-00)
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216145	ANDA	Fresenius Kabi USA, LLC	65219-403	65219-403-03	25 VIAL in 1 TRAY (65219-403-03) / 10 mL in 1 VIAL (65219-403-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Approval Date:	Dec 27, 2022	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:	Dec 27, 2022	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date:	Dec 27, 2022	TE:	AP	RLD:	No

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