Orange Book product · Brand (NDA)
BETOPTIC S
BETAXOLOL HYDROCHLORIDE
At a glance
Dec 29, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1989
37 yr ago
Today
Pharmaceutical detail
Active ingredient
BETAXOLOL HYDROCHLORIDE
Strength
EQ 0.25% BASE
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 019845
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1989KERLONEBrand (NDA)
NDA 019507 · SANOFI AVENTIS US
- 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.
