Prednisone

ANDA 89247, held by Sun Pharm Industries. Prednisone.

As of Nov 14, 2026, ANDA 89247 (Prednisone), held by Sun Pharm Industries, was first approved by FDA on Dec 4, 1985, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1985
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 4, 1985	Original application	Approved	None posted

Products

3 strengths and forms


Prednisone20MG · tablet;oral	Prednisone	Rx
Prednisone5MG · tablet;oral	Prednisone	Rx
Prednisone10MG · tablet;oral	Prednisone	Rx

All 21 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 39Labeling · Standard review	Approved	None posted
Dec 20, 2002	Supplement 19Manufacturing	Approved	None posted
Dec 17, 2002	Supplement 18Manufacturing	Approved	None posted
Jun 14, 2002	Supplement 15Manufacturing	Approved	None posted
May 20, 2002	Supplement 16Labeling	Approved	None posted
Oct 24, 2001	Supplement 17Labeling	Approved	None posted
Aug 10, 2000	Supplement 12Manufacturing	Approved	None posted
May 16, 2000	Supplement 14Manufacturing	Approved	None posted
May 16, 2000	Supplement 13Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 11Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 8Manufacturing	Approved	None posted
Oct 6, 1994	Supplement 7Labeling	Approved	None posted
Jan 12, 1994	Supplement 5Manufacturing	Approved	None posted
Jan 6, 1994	Supplement 6Labeling	Approved	None posted
Feb 8, 1990	Supplement 4Labeling	Approved	None posted
Feb 1, 1990	Supplement 3Manufacturing	Approved	None posted
Sep 6, 1988	Supplement 2Manufacturing	Approved	None posted
Sep 6, 1988	Supplement 1Labeling	Approved	None posted
Dec 4, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 89247
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