Inderide La 80/50, Inderide La 120/50, Inderide La 160/50

NDA 19059, held by Wyeth Ayerst. Hydrochlorothiazide; Propranolol Hydrochloride.

As of Nov 13, 2026, NDA 19059 (Inderide La 80/50, Inderide La 120/50, Inderide La 160/50), held by Wyeth Ayerst, was first approved by FDA on Jul 3, 1985, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1985
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 3, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Inderide La 80/5050MG;80MG · capsule, extended release;oral	Hydrochlorothiazide; Propranolol Hydrochloride	Discontinued
Inderide La 120/5050MG;120MG · capsule, extended release;oral	Hydrochlorothiazide; Propranolol Hydrochloride	Discontinued
Inderide La 160/5050MG;160MG · capsule, extended release;oral	Hydrochlorothiazide; Propranolol Hydrochloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 1, 2001	Supplement 16Labeling · Standard review	Approved	None posted
May 3, 2001	Supplement 17Labeling · Standard review	Approved	None posted
May 8, 1998	Supplement 15Labeling · Standard review	Approved	None posted
May 14, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 12, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 10, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 25, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
May 25, 1988	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 20, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 6, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 12, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 2, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 20, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 20, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 22, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 3, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19059
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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