Manganese Sulfate

NDA 19228, held by Abraxis Pharm. Manganese Sulfate.

As of Nov 13, 2026, NDA 19228 (Manganese Sulfate), held by Abraxis Pharm, was first approved by FDA on May 5, 1987, with 3 approved supplements and 0 published complete response letters.

First approved: May 5, 1987
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 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
Manganese SulfateEQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Manganese Sulfate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 25, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Jun 9, 1992	Supplement 3Labeling	Approved	None posted
Jun 7, 1989	Supplement 1Labeling	Approved	None posted
May 5, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19228
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