Prednisone

Controls severe or incapacitating allergic conditions. ANDA 84275, held by Chartwell Molecular. Prednisone.

As of Nov 14, 2026, ANDA 84275 (Prednisone), held by Chartwell Molecular, was first approved by FDA on Jun 27, 1974, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 27, 1974
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Prednisone tablets are indicated in the following conditions: 1. 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 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 27, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 7, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jun 7, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Mar 25, 1988	Supplement 8Labeling	Approved	None posted
Jun 27, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84275
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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