Orange Book product · Brand (NDA)
BETAGAN
LEVOBUNOLOL HYDROCHLORIDE
At a glance
Jun 28, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 1989
37 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOBUNOLOL HYDROCHLORIDE
Strength
0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 019814
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1985BETAGANBrand (NDA)
NDA 019219 · ALLERGAN
- 2000LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075473 · APOTEX INC
- 2000LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075475 · APOTEX INC
- 1996AKBETAGeneric (ANDA)
ANDA 074779 · EPIC PHARMA LLC
- 1996AKBETAGeneric (ANDA)
ANDA 074780 · EPIC PHARMA LLC
- 1996LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 074851 · ALCON LABS INC
- 1996LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 074850 · CHARTWELL RX
- 1994LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 074307 · BAUSCH AND LOMB
- 1994LEVOBUNOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 074326 · BAUSCH AND LOMB INC
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.
