Orange Book product · Generic (ANDA)
ULTACAN
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
At a glance
Jul 11, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 11, 2017
9 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Strength
4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 201751
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
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.
