Inderal

NDA 19536, held by Wyeth Ayerst. Propranolol Hydrochloride.

As of Nov 13, 2026, NDA 19536 (Inderal), held by Wyeth Ayerst, was first approved by FDA on Dec 12, 1986, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1986
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 12, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Inderal10MG/ML · suspension;oral	Propranolol Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 14, 1990	Supplement 2Labeling · Standard review	Approved	None posted
Jan 14, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 12, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19536
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