Orange Book product · Generic (ANDA)
METHYLNALTREXONE BROMIDE
METHYLNALTREXONE BROMIDE
Generic (ANDA)ANDA 208592DISCN MYLAN LABS LTD
At a glance
May 28, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLNALTREXONE BROMIDE
Strength
12MG/0.6ML (12MG/0.6ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
ANDA 208592
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHYLNALTREXONE BROMIDE
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.
