Florinef

NDA 10060, held by Casper Pharma LLC. Fludrocortisone Acetate.

As of Nov 13, 2026, NDA 10060 (Florinef), held by Casper Pharma LLC, was first approved by FDA on Aug 18, 1955, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 18, 1955
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 18, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Florinef0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fludrocortisone Acetate	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 29, 2004	Supplement 17Labeling · Standard review	Approved	Letter
Aug 20, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 24, 1995	Supplement 15Labeling · Standard review	Approved	None posted
Oct 11, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 31, 1993	Supplement 13Labeling	Approved	None posted
May 9, 1988	Supplement 12Labeling	Approved	None posted
Nov 18, 1982	Supplement 10Labeling	Approved	None posted
Jan 22, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 18, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10060
Drugs@FDA: Overview at FDA
Company: Casper Pharma

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