Orange Book product · Brand (NDA)
ORLAAM
LEVOMETHADYL ACETATE HYDROCHLORIDE
At a glance
Jul 09, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 1993
33 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOMETHADYL ACETATE HYDROCHLORIDE
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CONCENTRATE
Route
ORAL
TE code
Not listed
Application
NDA 020315
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
