Prednicen-M

ANDA 84655, held by Schwarz Pharma. Prednisone.

As of Nov 14, 2026, ANDA 84655 (Prednicen-M), held by Schwarz Pharma, was first approved by FDA on Dec 9, 1975, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 9, 1975
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
Dec 9, 1975	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednicen-M5MG · tablet;oral	Prednisone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 15, 1996	Supplement 19Labeling	Approved	None posted
Jan 31, 1994	Supplement 18Labeling	Approved	None posted
Jan 19, 1990	Supplement 10Labeling	Approved	None posted
Oct 18, 1989	Supplement 9Labeling	Approved	None posted
May 8, 1989	Supplement 8Labeling	Approved	None posted
Dec 9, 1975	Original application	Approved	Review

Identifiers

Application: ANDA 84655
Drugs@FDA: Overview at FDA
Company: Schwarz Pharma

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