Ionamin

NDA 11613, held by Ucb Inc. Phentermine Resin Complex.

As of Nov 13, 2026, NDA 11613 (Ionamin), held by Ucb Inc, was first approved by FDA on May 4, 1959, with 18 approved supplements and 0 published complete response letters.

First approved: May 4, 1959
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 4, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


IonaminEQ 30MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Phentermine Resin Complex	Discontinued
IonaminEQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Phentermine Resin Complex	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 5, 2012	Supplement 27Labeling	Approved	Letter Label
Oct 8, 2003	Supplement 26Labeling · Standard review	Approved	Letter
Feb 27, 1998	Supplement 23Labeling · Standard review	Approved	None posted
Feb 17, 1998	Supplement 24Labeling · Standard review	Approved	None posted
Jul 8, 1993	Supplement 21Manufacturing · Priority review	Approved	None posted
Aug 3, 1987	Supplement 20Manufacturing · Priority review	Approved	None posted
Jul 10, 1987	Supplement 19Manufacturing · Priority review	Approved	None posted
May 4, 1987	Supplement 18Manufacturing · Priority review	Approved	None posted
Dec 31, 1985	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 4, 1985	Supplement 17Labeling	Approved	None posted
Jul 23, 1985	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 7, 1984	Supplement 11Labeling	Approved	None posted
Jun 16, 1983	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 20, 1983	Supplement 12Manufacturing · Priority review	Approved	None posted
Sep 25, 1980	Supplement 10Labeling	Approved	None posted
May 2, 1980	Supplement 9Manufacturing · Priority review	Approved	None posted
Oct 31, 1978	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 10, 1975	Supplement 6Labeling	Approved	None posted
May 4, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 11613
Drugs@FDA: Overview at FDA
Company: UCB

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