Prednisone

Controls severe or incapacitating allergic conditions. ANDA 80356, held by Watson Labs. Prednisone.

As of Nov 14, 2026, ANDA 80356 (Prednisone), held by Watson Labs, was first approved by FDA on Jan 17, 1972, with 24 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1972
Supplements approved: 24
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 25 submissions below

Date	Submission	Status	Documents
Jan 17, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG · tablet;oral	Prednisone	Rx

All 25 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 116Labeling · Standard review	Approved	None posted
May 28, 2024	Supplement 110Labeling · Standard review	Approved	None posted
Apr 25, 2001	Supplement 79Manufacturing	Approved	None posted
Jun 15, 1998	Supplement 75Manufacturing	Approved	None posted
Jun 15, 1998	Supplement 74Manufacturing	Approved	None posted
Jun 16, 1997	Supplement 73Manufacturing	Approved	None posted
Nov 14, 1995	Supplement 72Labeling	Approved	None posted
Feb 8, 1994	Supplement 71Labeling	Approved	None posted
Jan 28, 1991	Supplement 68Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 66Manufacturing	Approved	None posted
Feb 17, 1988	Supplement 65Manufacturing	Approved	None posted
Feb 17, 1988	Supplement 64Manufacturing	Approved	None posted
Nov 19, 1987	Supplement 61Manufacturing	Approved	None posted
Nov 19, 1987	Supplement 60Manufacturing	Approved	None posted
Oct 9, 1987	Supplement 63Manufacturing	Approved	None posted
Sep 8, 1987	Supplement 62Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 58Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 57Manufacturing	Approved	None posted
Dec 15, 1983	Supplement 55Manufacturing	Approved	None posted
Dec 8, 1983	Supplement 54Manufacturing	Approved	None posted
Aug 23, 1983	Supplement 53Manufacturing	Approved	None posted
Jul 20, 1983	Supplement 52Manufacturing	Approved	None posted
Jul 20, 1983	Supplement 51Manufacturing	Approved	None posted
Mar 30, 1972	Supplement 1Manufacturing	Approved	None posted
Jan 17, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80356
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