Prednisone

Controls severe or incapacitating allergic conditions. ANDA 208412, held by Strides Pharma. Prednisone.

As of Nov 14, 2026, ANDA 208412 (Prednisone), held by Strides Pharma, was first approved by FDA on Feb 11, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 11, 2021
Review: Standard
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Feb 11, 2021	Original application	Approved	None posted

Products

5 strengths and forms


Prednisone10MG · tablet;oral	Prednisone	Rx
Prednisone20MG · tablet;oral	Prednisone	Rx
Prednisone50MG · tablet;oral	Prednisone	Rx
Prednisone2.5MG · tablet;oral	Prednisone	Rx
Prednisone5MG · tablet;oral	Prednisone	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Feb 11, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 208412
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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