FDA Orange Book · active-ingredient family
Naphazoline hydrochloride
Naphazoline hydrochloride is approved in 7 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAFAZAIR | BAUSCH AND LOMB | ANDA 040073 | — | May 25, 1994 | |
| NAFAZAIR | PHARMAFAIR | ANDA 088101 | — | Apr 15, 1983 | |
| VASOCON | NOVARTIS | ANDA 080235 | — | Mar 24, 1983 | |
| ALBALON | ALLERGAN | ANDA 080248 | — | Approved Prior to Jan 1, 1982 | |
| NAPHAZOLINE HYDROCHLORIDE | RISING | ANDA 083590 | — | Approved Prior to Jan 1, 1982 | |
| NAPHCON FORTERLD | ALCON | ANDA 080229 | — | Approved Prior to Jan 1, 1982 | |
| OPCON | BAUSCH AND LOMB | ANDA 087506 | — | Approved Prior to Jan 1, 1982 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
