Prednisone

ANDA 86596, held by Sun Pharm Industries. Prednisone.

As of Nov 14, 2026, ANDA 86596 (Prednisone), held by Sun Pharm Industries, was first approved by FDA on Apr 10, 1979, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1979
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 10, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone50MG · tablet;oral	Prednisone	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Dec 1, 1998	Supplement 23Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 20Labeling	Approved	None posted
Dec 23, 1994	Supplement 22Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 21Manufacturing	Approved	None posted
Apr 4, 1994	Supplement 19Labeling	Approved	None posted
Apr 3, 1992	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 18Manufacturing	Approved	None posted
Mar 27, 1991	Supplement 15Labeling	Approved	None posted
Apr 1, 1987	Supplement 13Manufacturing	Approved	None posted
Mar 20, 1986	Supplement 11Manufacturing	Approved	None posted
Apr 10, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86596
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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