FDA Orange Book · active-ingredient family
Levobunolol hydrochloride
Levobunolol hydrochloride is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BETAGAN · NDA 019814
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETAGANRLD | ALLERGAN | NDA 019814 | — | Jun 28, 1989 | |
| BETAGANRLD | ALLERGAN | NDA 019219 | AT | Dec 19, 1985 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOBUNOLOL HYDROCHLORIDE | APOTEX INC | ANDA 075473 | — | Aug 03, 2000 | |
| LEVOBUNOLOL HYDROCHLORIDE | APOTEX INC | ANDA 075475 | — | Aug 03, 2000 | |
| AKBETA | EPIC PHARMA LLC | ANDA 074779 | — | Oct 29, 1996 | |
| AKBETA | EPIC PHARMA LLC | ANDA 074780 | — | Oct 29, 1996 | |
| LEVOBUNOLOL HYDROCHLORIDE | ALCON LABS INC | ANDA 074851 | — | Oct 28, 1996 | |
| LEVOBUNOLOL HYDROCHLORIDE | CHARTWELL RX | ANDA 074850 | — | Oct 28, 1996 | |
| LEVOBUNOLOL HYDROCHLORIDE | BAUSCH AND LOMB | ANDA 074307 | — | Mar 04, 1994 | |
| LEVOBUNOLOL HYDROCHLORIDE | BAUSCH AND LOMB INC | ANDA 074326 | AT | Mar 04, 1994 |
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.
Levobunolol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
