Orange Book product · Generic (ANDA)
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Generic (ANDA)ANDA 202795OTC RISING
At a glance
Jan 24, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2013
13 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Strength
0.025%;0.3%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 202795
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
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.
