Cupric Sulfate

NDA 19350, held by Abraxis Pharm. Cupric Sulfate.

As of Nov 14, 2026, NDA 19350 (Cupric Sulfate), held by Abraxis Pharm, was first approved by FDA on May 5, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: May 5, 1987
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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
Cupric SulfateEQ 0.4MG COPPER/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cupric Sulfate	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jun 9, 1992	Supplement 3Labeling · Standard review	Approved	None posted
May 15, 1990	Supplement 2Labeling · Standard review	Approved	None posted
May 5, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19350
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