Prednisone

ANDA 85151, held by Pvt Form. Prednisone.

As of Nov 14, 2026, ANDA 85151 (Prednisone), held by Pvt Form, was first approved by FDA on Aug 26, 1976, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1976
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, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 21, 1985	Supplement 15Manufacturing	Approved	None posted
Oct 21, 1985	Supplement 16Manufacturing	Approved	None posted
Oct 7, 1985	Supplement 12Manufacturing	Approved	None posted
Oct 7, 1985	Supplement 13Manufacturing	Approved	None posted
Oct 7, 1985	Supplement 14Manufacturing	Approved	None posted
Aug 26, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85151
Drugs@FDA: Overview at FDA
Company: PVT FORM

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