Prednisolone Acetate

ANDA 83764, held by Watson Labs. Prednisolone Acetate.

As of Nov 15, 2026, ANDA 83764 (Prednisolone Acetate), held by Watson Labs, was first approved by FDA on Feb 13, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1974
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Feb 13, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone Acetate50MG/ML · injectable;injection	Prednisolone Acetate	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 195Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 194Manufacturing	Approved	None posted
Jun 8, 1998	Supplement 193Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 192Manufacturing	Approved	None posted
Apr 15, 1991	Supplement 190Labeling	Approved	None posted
Jan 11, 1991	Supplement 188Manufacturing	Approved	None posted
Jan 11, 1991	Supplement 187Manufacturing	Approved	None posted
Nov 8, 1989	Supplement 189Labeling	Approved	None posted
Dec 30, 1988	Supplement 182Bioequivalence	Approved	None posted
Jun 16, 1986	Supplement 181Manufacturing	Approved	None posted
Oct 31, 1984	Supplement 180Manufacturing	Approved	None posted
Sep 17, 1982	Supplement 179Manufacturing	Approved	None posted
May 19, 1982	Supplement 178Manufacturing	Approved	None posted
Apr 5, 1982	Supplement 177Manufacturing	Approved	None posted
Feb 13, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 83764
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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