Flo-Pred

NDA 22067, held by Sun Pharma Canada. Prednisolone Acetate.

As of Nov 14, 2026, NDA 22067 (Flo-Pred), held by Sun Pharma Canada, was first approved by FDA on Jan 17, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2008
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jan 17, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Flo-PredEQ 5MG BASE/5ML · suspension;oral	Prednisolone Acetate	Discontinued
Flo-PredEQ 15MG BASE/5ML · suspension;oral	Prednisolone Acetate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 15, 2021	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 3, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 29, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 14, 2011	Supplement 7Labeling	Approved	Letter Label
May 6, 2010	Supplement 4Manufacturing · Standard review	Approved	Label Letter
Oct 3, 2008	Supplement 2Manufacturing	Approved	Label Letter
Jun 27, 2008	Supplement 1Manufacturing	Approved	Letter Label
Jan 17, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22067
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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