Omnipred

NDA 17469, held by Sandoz. Prednisolone Acetate.

As of Nov 14, 2026, NDA 17469 (Omnipred), held by Sandoz, was first approved by FDA on Jul 10, 1973, with 34 approved supplements and 0 published complete response letters.

First approved: Jul 10, 1973
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Aug 29, 1995	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 10, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omnipred1% · suspension/drops;ophthalmic	Prednisolone Acetate	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Dec 18, 2024	Supplement 54Labeling · Standard review	Approved	Label Letter
Mar 4, 2022	Supplement 47Labeling · Standard review	Approved	Label Letter
Oct 11, 2007	Supplement 40Labeling · Standard review	Approved	Letter Label
May 15, 2006	Supplement 38Labeling · Standard review	Approved	Label
May 15, 2006	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 17, 2003	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 11, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 4, 2002	Supplement 29Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 5, 1999	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 9, 1999	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 6, 1998	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 4, 1998	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 27, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 5, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 29, 1995	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 13, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 22, 1991	Supplement 14Labeling	Approved	None posted
Apr 10, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 6, 1989	Supplement 11Labeling	Approved	None posted
Mar 2, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 12, 1986	Supplement 12Manufacturing · Standard review	Approved	None posted
May 25, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
May 24, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 7Labeling	Approved	None posted
Apr 6, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 6, 1977	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 6, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 6, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 5, 1974	Supplement 1Labeling	Approved	None posted
Jul 10, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17469
Drugs@FDA: Overview at FDA
Company: Sandoz

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