Ismelin

NDA 12329, held by Novartis. Guanethidine Monosulfate.

As of Nov 13, 2026, NDA 12329 (Ismelin), held by Novartis, was first approved by FDA on Jul 5, 1960, with 30 approved supplements and 0 published complete response letters.

First approved: Jul 5, 1960
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Jul 5, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


IsmelinEQ 10MG SULFATE · tablet;oral	Guanethidine Monosulfate	Discontinued
IsmelinEQ 25MG SULFATE · tablet;oral	Guanethidine Monosulfate	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Oct 22, 1986	Supplement 54Labeling	Approved	None posted
May 5, 1986	Supplement 53Labeling	Approved	None posted
May 5, 1986	Supplement 52Labeling	Approved	None posted
May 5, 1986	Supplement 50Labeling	Approved	None posted
Mar 19, 1985	Supplement 51Manufacturing · Priority review	Approved	None posted
Feb 2, 1981	Supplement 49Manufacturing · Priority review	Approved	None posted
Dec 12, 1980	Supplement 48Labeling	Approved	None posted
May 8, 1980	Supplement 47Labeling	Approved	None posted
Jan 24, 1980	Supplement 46Manufacturing · Priority review	Approved	None posted
Jan 17, 1980	Supplement 45Manufacturing · Priority review	Approved	None posted
Jun 25, 1979	Supplement 44Manufacturing · Priority review	Approved	None posted
Jun 25, 1979	Supplement 43Manufacturing · Priority review	Approved	None posted
Jun 25, 1979	Supplement 42Manufacturing · Priority review	Approved	None posted
Feb 12, 1979	Supplement 39Manufacturing · Priority review	Approved	None posted
Jan 31, 1979	Supplement 40Manufacturing · Priority review	Approved	None posted
Jan 8, 1979	Supplement 41Labeling	Approved	None posted
Jun 29, 1977	Supplement 38Manufacturing · Priority review	Approved	None posted
Apr 12, 1977	Supplement 37Manufacturing · Priority review	Approved	None posted
Dec 29, 1976	Supplement 35Manufacturing · Priority review	Approved	None posted
Dec 2, 1976	Supplement 36Manufacturing · Priority review	Approved	None posted
Mar 19, 1976	Supplement 33Manufacturing · Priority review	Approved	None posted
Feb 3, 1976	Supplement 34Manufacturing · Priority review	Approved	None posted
Sep 26, 1975	Supplement 25Labeling	Approved	None posted
Sep 26, 1975	Supplement 22Labeling	Approved	None posted
Jul 2, 1975	Supplement 32Manufacturing · Priority review	Approved	None posted
May 15, 1975	Supplement 26REMS · Priority review	Approved	None posted
May 15, 1975	Supplement 23REMS · Priority review	Approved	None posted
Mar 31, 1975	Supplement 30Manufacturing · Priority review	Approved	None posted
Mar 31, 1975	Supplement 29Manufacturing · Priority review	Approved	None posted
Mar 31, 1975	Supplement 28Manufacturing · Priority review	Approved	None posted
Jul 5, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12329
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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