FDA Orange Book · active-ingredient family
Naphazoline hydrochloride; pheniramine maleate
Naphazoline hydrochloride; pheniramine maleate is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VISINE · NDA 020485
3
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VISINERLD | KENVUE BRANDS | NDA 020485 | — | Jan 31, 1996 | |
| NAPHCON-ARLD | ALCON | NDA 020226 | — | Jun 08, 1994 | |
| OPCON-ARLD | BAUSCH AND LOMB | NDA 020065 | — | Jun 08, 1994 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | RISING | ANDA 202795 | — | Jan 24, 2013 | |
| NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | ALTAIRE PHARMS INC | ANDA 078208 | — | Sep 27, 2010 |
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.
Naphazoline hydrochloride; pheniramine maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
