Orange Book product · Generic (ANDA)
NALTREXONE
NALTREXONE
Generic (ANDA)ANDA 213195DISCN TEVA PHARMS USA INC
At a glance
Jul 06, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 06, 2023
3 yr ago
Today
Pharmaceutical detail
Active ingredient
NALTREXONE
Strength
380MG/VIAL
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
ANDA 213195
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NALTREXONE
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.
