Protostat

NDA 18871, held by Ortho Mcneil Pharm. Metronidazole.

As of Nov 13, 2026, NDA 18871 (Protostat), held by Ortho Mcneil Pharm, was first approved by FDA on Mar 2, 1983, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 2, 1983
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
Mar 2, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Protostat250MG · tablet;oral	Metronidazole	Discontinued
Protostat500MG · tablet;oral	Metronidazole	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 11, 1992	Supplement 19Labeling	Approved	None posted
Dec 20, 1988	Supplement 18Labeling	Approved	None posted
Jul 22, 1988	Supplement 17Labeling	Approved	None posted
Mar 2, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18871
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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