Prednisolone

ANDA 85085, held by Watson Labs. Prednisolone.

As of Nov 15, 2026, ANDA 85085 (Prednisolone), held by Watson Labs, was first approved by FDA on Jun 29, 1976, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1976
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jun 29, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone5MG · tablet;oral	Prednisolone	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 6, 1994	Supplement 25Labeling	Approved	None posted
Jan 6, 1994	Supplement 24Labeling	Approved	None posted
Mar 3, 1988	Supplement 23Labeling	Approved	None posted
Dec 1, 1987	Supplement 22Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 17Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 18Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 19Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 20Manufacturing	Approved	None posted
Dec 23, 1986	Supplement 16Manufacturing	Approved	None posted
Feb 14, 1986	Supplement 15Manufacturing	Approved	None posted
Mar 19, 1984	Supplement 14Labeling	Approved	None posted
Mar 29, 1983	Supplement 8Manufacturing	Approved	None posted
Oct 4, 1982	Supplement 9Manufacturing	Approved	None posted
Jun 29, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85085
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