Prednisone

Controls severe or incapacitating allergic conditions. ANDA 85161, held by Watson Labs. Prednisone.

As of Nov 14, 2026, ANDA 85161 (Prednisone), held by Watson Labs, was first approved by FDA on Nov 11, 1976, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 11, 1976
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Prednisone tablets, USP are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Nov 11, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Rx

All 20 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 97Labeling · Standard review	Approved	None posted
May 28, 2024	Supplement 91Labeling · Standard review	Approved	None posted
Apr 25, 2001	Supplement 57Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 54Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 53Manufacturing	Approved	None posted
Nov 14, 1995	Supplement 52Labeling	Approved	None posted
Feb 8, 1994	Supplement 51Labeling	Approved	None posted
Aug 7, 1991	Supplement 47Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 48Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 46Manufacturing	Approved	None posted
Aug 9, 1988	Supplement 45Manufacturing	Approved	None posted
Aug 9, 1988	Supplement 44Manufacturing	Approved	None posted
Nov 23, 1987	Supplement 43Manufacturing	Approved	None posted
Nov 23, 1987	Supplement 42Manufacturing	Approved	None posted
Jun 4, 1985	Supplement 35Manufacturing	Approved	None posted
Jan 11, 1984	Supplement 33Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 32Manufacturing	Approved	None posted
Sep 7, 1983	Supplement 31Manufacturing	Approved	None posted
Sep 7, 1983	Supplement 29Manufacturing	Approved	None posted
Nov 11, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85161
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