Orange Book product · Generic (ANDA)
FOMEPIZOLE
FOMEPIZOLE
Generic (ANDA)ANDA 078639TE APRX MYLAN INSTITUTIONAL
At a glance
Mar 03, 2008
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 03, 2008
18 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
FOMEPIZOLE
Strength
1.5GM/1.5ML (1GM/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078639
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of FOMEPIZOLE
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.
