Prednisone

ANDA 87772, held by Watson Labs. Prednisone.

As of Nov 14, 2026, ANDA 87772 (Prednisone), held by Watson Labs, was first approved by FDA on Jul 13, 1982, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1982
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jul 13, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone50MG · tablet;oral	Prednisone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Jul 7, 1999	Supplement 17Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 13Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 15Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 16Manufacturing	Approved	None posted
Apr 1, 1996	Supplement 12Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 11Labeling	Approved	None posted
Dec 23, 1993	Supplement 10Labeling	Approved	None posted
Feb 5, 1991	Supplement 9Labeling	Approved	None posted
Mar 9, 1989	Supplement 7Manufacturing	Approved	None posted
Dec 11, 1986	Supplement 4Manufacturing	Approved	None posted
Sep 4, 1986	Supplement 5Manufacturing	Approved	None posted
Jul 13, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87772
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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