Prednisone

ANDA 86813, held by Watson Labs. Prednisone.

As of Nov 14, 2026, ANDA 86813 (Prednisone), held by Watson Labs, was first approved by FDA on Jun 1, 1979, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1979
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 1, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Feb 20, 1998	Supplement 25Manufacturing	Approved	None posted
Feb 20, 1998	Supplement 26Manufacturing	Approved	None posted
Feb 20, 1998	Supplement 27Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 24Labeling	Approved	None posted
Dec 23, 1993	Supplement 23Labeling	Approved	None posted
Feb 5, 1991	Supplement 22Labeling	Approved	None posted
Aug 19, 1987	Supplement 21Manufacturing	Approved	None posted
Aug 1, 1986	Supplement 19Manufacturing	Approved	None posted
Jun 10, 1983	Supplement 10Manufacturing	Approved	None posted
Jun 10, 1983	Supplement 11Manufacturing	Approved	None posted
Jul 21, 1982	Supplement 2Manufacturing	Approved	None posted
Jul 21, 1982	Supplement 3Manufacturing	Approved	None posted
Jul 21, 1982	Supplement 7Manufacturing	Approved	None posted
Jul 21, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 1, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86813
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