Prednisone

ANDA 85084, held by Watson Labs. Prednisone.

As of Nov 14, 2026, ANDA 85084 (Prednisone), held by Watson Labs, was first approved by FDA on Jun 23, 1976, with 20 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1976
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jun 23, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Mar 30, 1998	Supplement 46Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 45Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 44Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 43Labeling	Approved	None posted
Dec 23, 1993	Supplement 42Labeling	Approved	None posted
Feb 5, 1991	Supplement 41Labeling	Approved	None posted
Jun 22, 1988	Supplement 40Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 39Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 38Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 37Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 36Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 35Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 34Manufacturing	Approved	None posted
Dec 11, 1986	Supplement 14Manufacturing	Approved	None posted
Jun 29, 1984	Supplement 25Manufacturing	Approved	None posted
Sep 24, 1982	Supplement 24Manufacturing	Approved	None posted
Sep 24, 1982	Supplement 22Manufacturing	Approved	None posted
Dec 15, 1981	Supplement 20Manufacturing	Approved	None posted
Dec 15, 1981	Supplement 18Manufacturing	Approved	None posted
Dec 15, 1981	Supplement 17Manufacturing	Approved	None posted
Jun 23, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85084
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