Details for New Drug Application (NDA): 216135

NDA 216135 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 216135

Tradename:	ZINC SULFATE
Applicant:	Somerset Theraps Llc
Ingredient:	zinc sulfate
Patents:	0

Pharmacology for NDA: 216135

Physiological Effect

Decreased Copper Ion Absorption

Medical Subject Heading (MeSH) Categories for 216135

Astringents

Suppliers and Packaging for NDA: 216135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216135	ANDA	Somerset Therapeutics, LLC	70069-691	70069-691-25	25 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01)
ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216135	ANDA	Somerset Therapeutics, LLC	70069-692	70069-692-25	25 VIAL in 1 CARTON (70069-692-25) / 10 mL in 1 VIAL (70069-692-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
Approval Date:	Jul 17, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
Approval Date:	Jul 17, 2024	TE:	AP	RLD:	No

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