Prednisone

ANDA 88865, held by Superpharm. Prednisone.

As of Nov 14, 2026, ANDA 88865 (Prednisone), held by Superpharm, was first approved by FDA on Oct 25, 1984, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 25, 1984
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 25, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 12, 1989	Supplement 9Labeling	Approved	None posted
Oct 25, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88865
Drugs@FDA: Overview at FDA
Company: Superpharm

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