Trandate

NDA 18716, held by Alvogen. Labetalol Hydrochloride.

As of Nov 13, 2026, NDA 18716 (Trandate), held by Alvogen, was first approved by FDA on Aug 1, 1984, with 26 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1984
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Aug 1, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Trandate100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Trandate200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Trandate300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug
Trandate400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Labetalol Hydrochloride	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Apr 25, 2024	Supplement 36Labeling · Standard review	Approved	Label Letter
Apr 27, 2016	Supplement 28Labeling · Standard review	Approved	Label Letter
Oct 27, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 22, 2010	Supplement 26Labeling	Approved	Letter Label
Feb 1, 2008	Supplement 25Labeling · Standard review	Approved	None posted
Apr 23, 2003	Supplement 23Manufacturing · Standard review	Approved	Letter
Aug 13, 1998	Supplement 22Labeling · Standard review	Approved	None posted
Apr 21, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
May 27, 1993	Supplement 18Labeling	Approved	None posted
May 27, 1993	Supplement 20Labeling · Standard review	Approved	None posted
Jun 5, 1991	Supplement 19Labeling	Approved	None posted
Feb 1, 1991	Supplement 17Labeling	Approved	None posted
Nov 7, 1990	Supplement 15Labeling	Approved	None posted
Jun 7, 1990	Supplement 16Labeling	Approved	None posted
Dec 22, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 16, 1989	Supplement 11Labeling	Approved	None posted
Jun 16, 1989	Supplement 12Labeling	Approved	None posted
Apr 7, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 22, 1987	Supplement 9Labeling	Approved	None posted
Aug 27, 1987	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 13, 1986	Supplement 8Labeling	Approved	None posted
Aug 8, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
May 24, 1985	Supplement 5Labeling	Approved	None posted
May 24, 1985	Supplement 6Labeling	Approved	None posted
Apr 16, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 26, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 1, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18716
Drugs@FDA: Overview at FDA
Company: Alvogen

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