Orange Book product · Generic (ANDA)
DYCLOPRO
DYCLONINE HYDROCHLORIDE
Generic (ANDA)ANDA 200480RX SEPTODONT
At a glance
Nov 20, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2018
7 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DYCLONINE HYDROCHLORIDE
Strength
0.5%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
ANDA 200480
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of DYCLONINE HYDROCHLORIDE
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.
