Orlaam

NDA 20315, held by Roxane. Levomethadyl Acetate Hydrochloride.

As of Nov 14, 2026, NDA 20315 (Orlaam), held by Roxane, was first approved by FDA on Jul 9, 1993, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 9, 1993
Review: Priority
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 9, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orlaam10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · concentrate;oral	Levomethadyl Acetate Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 10Labeling · Standard review	Approved	None posted
May 17, 2001	Supplement 9Labeling · Standard review	Approved	None posted
Mar 30, 2001	Supplement 6Labeling · Standard review	Approved	Letter
Mar 1, 2001	Supplement 7Manufacturing · Priority review	Approved	None posted
Jul 2, 1998	Supplement 5Manufacturing · Priority review	Approved	None posted
Aug 8, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
Jul 16, 1997	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 27, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 27, 1996	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 9, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20315
Drugs@FDA: Overview at FDA
Company: Roxane 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