Orange Book product · Brand (NDA)
KERLONE
BETAXOLOL HYDROCHLORIDE
At a glance
Oct 27, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 1989
37 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BETAXOLOL HYDROCHLORIDE
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019507
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1989BETOPTIC SBrand (NDA)
NDA 019845 · NOVARTIS
- 1985BETOPTICBrand (NDA)
NDA 019270 · SANDOZ
- 2009BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 078694 · CHARTWELL RX
- 2008BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 078962 · KVK TECH
- 2001BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075630 · EUROFARMA
- 2000BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075446 · APOTEX INC
- 2000BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075386 · PHARMOBEDIENT
- 1999BETAXOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075541 · EPIC PHARMA
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.
