Vasocidin

NDA 18988, held by Novartis. Prednisolone Sodium Phosphate; Sulfacetamide Sodium.

As of Nov 13, 2026, NDA 18988 (Vasocidin), held by Novartis, was first approved by FDA on Aug 26, 1988, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1988
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 26, 1988	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
VasocidinEQ 0.23% PHOSPHATE;10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Prednisolone Sodium Phosphate; Sulfacetamide Sodium	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 26, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 7, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
May 9, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 8, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Jan 10, 1992	Supplement 3Labeling · Standard review	Approved	None posted
Aug 26, 1988	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18988
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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