Hepatolite

NDA 18467, held by Sun Pharm Inds Inc. Technetium Tc-99m Disofenin Kit.

As of Nov 13, 2026, NDA 18467 (Hepatolite), held by Sun Pharm Inds Inc, was first approved by FDA on Mar 16, 1982, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 16, 1982
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Dec 29, 1993	Supplement 14Efficacy (new indication or use)	Approved	Review
May 19, 1989	Supplement 9Efficacy (new indication or use)	Approved	None posted
Mar 16, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HepatoliteN/A · injectable;injection	Technetium Tc-99m Disofenin Kit	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Oct 30, 2015	Supplement 31Manufacturing · Priority review	Approved	None posted
Apr 25, 2013	Supplement 25Manufacturing · Priority review	Approved	None posted
May 16, 2002	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 15, 2000	Supplement 17Manufacturing · Priority review	Approved	None posted
Feb 7, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
Nov 5, 1997	Supplement 15Manufacturing · Priority review	Approved	None posted
Dec 29, 1993	Supplement 14Efficacy (new indication or use)	Approved	Review
Dec 29, 1993	Supplement 13Labeling	Approved	Review
May 19, 1989	Supplement 11Manufacturing · Priority review	Approved	None posted
May 19, 1989	Supplement 10Labeling	Approved	None posted
May 19, 1989	Supplement 9Efficacy (new indication or use)	Approved	None posted
May 19, 1989	Supplement 7Manufacturing · Priority review	Approved	None posted
May 2, 1989	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 28, 1986	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 7, 1983	Supplement 2Labeling	Approved	None posted
Apr 26, 1983	Supplement 1Manufacturing · Priority review	Approved	None posted
Apr 21, 1983	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 16, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18467
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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