FDA Orange Book · active-ingredient family
Betaxolol hydrochloride
Betaxolol hydrochloride is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BETOPTIC S · NDA 019845
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops, suspension/drops, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETOPTIC SRLD | NOVARTIS | NDA 019845 | — | Dec 29, 1989 | |
| BETOPTICRLD | SANDOZ | NDA 019270 | AT | Aug 30, 1985 | |
| KERLONE×2 | SANOFI AVENTIS US | NDA 019507 | — | Oct 27, 1989 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | CHARTWELL RX | ANDA 078694 | AT | Nov 16, 2009 | |
| BETAXOLOL HYDROCHLORIDE×2 | KVK TECH | ANDA 078962 | AB | Jun 27, 2008 | |
| BETAXOLOL HYDROCHLORIDE | EUROFARMA | ANDA 075630 | AT | Apr 12, 2001 | |
| BETAXOLOL HYDROCHLORIDE | APOTEX INC | ANDA 075446 | — | Sep 28, 2000 | |
| BETAXOLOL HYDROCHLORIDE | PHARMOBEDIENT | ANDA 075386 | — | Jun 30, 2000 | |
| BETAXOLOL HYDROCHLORIDE×2 | EPIC PHARMA | ANDA 075541 | AB | Oct 22, 1999 |
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.
Betaxolol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
