Aquasol A

Treats vitamin A deficiency. NDA 6823, held by Casper Pharma LLC. Vitamin A Palmitate.

As of Nov 13, 2026, NDA 6823 (Aquasol A), held by Casper Pharma LLC, was first approved by FDA on May 18, 1949, with 13 approved supplements and 0 published complete response letters.

First approved: May 18, 1949
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
May 18, 1949	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aquasol AEQ 50,000 UNITS BASE/ML · injectable;injection	Vitamin A Palmitate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Sep 18, 2015	Supplement 19Manufacturing	Approved	None posted
Nov 11, 2014	Supplement 18Manufacturing	Approved	None posted
Jun 9, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Dec 1, 1999	Supplement 16Manufacturing	Approved	None posted
Apr 27, 1998	Supplement 15Manufacturing	Approved	None posted
Feb 2, 1993	Supplement 13Manufacturing	Approved	None posted
Dec 7, 1990	Supplement 12Manufacturing	Approved	None posted
Jul 21, 1989	Supplement 11Labeling	Approved	None posted
Sep 19, 1984	Supplement 8Labeling	Approved	None posted
Sep 19, 1984	Supplement 9Labeling	Approved	None posted
Oct 3, 1983	Supplement 6Labeling	Approved	None posted
Apr 20, 1982	Supplement 5Labeling	Approved	None posted
Jan 30, 1980	Supplement 4Labeling	Approved	None posted
May 18, 1949	Original application	Approved	None posted

Identifiers

Application: NDA 6823
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