Zinc Sulfate

NDA 19229, held by Abraxis Pharm. Zinc Sulfate.

As of Nov 14, 2026, NDA 19229 (Zinc Sulfate), held by Abraxis Pharm, was first approved by FDA on May 5, 1987, with 1 approved supplement and 0 published complete response letters.

First approved: May 5, 1987
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 5, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zinc SulfateEQ 1MG ZINC/ML · injectable;injection	Zinc Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 6, 1989	Supplement 1Labeling · Standard review	Approved	None posted
May 5, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19229
Drugs@FDA: Overview at FDA
Company: Abraxis Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters