Betaprone

NDA 11657, held by Forest Labs. Propiolactone.

As of Nov 14, 2026, NDA 11657 (Betaprone), held by Forest Labs, was first approved by FDA on Jun 12, 1959, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 12, 1959
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 12, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
BetaproneN/A · solution;irrigation	Propiolactone	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 26, 1996	Supplement 14Labeling	Approved	None posted
Apr 26, 1996	Supplement 12Labeling	Approved	None posted
Apr 26, 1996	Supplement 9Labeling	Approved	None posted
May 8, 1981	Supplement 10Labeling	Approved	None posted
May 16, 1977	Supplement 8Labeling	Approved	None posted
Nov 9, 1976	Supplement 7Labeling	Approved	None posted
Nov 9, 1976	Supplement 6Labeling	Approved	None posted
Jun 12, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11657
Drugs@FDA: Overview at FDA
Company: Forest Laboratories

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