Orange Book product · Generic (ANDA)
BETAXOLOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE
At a glance
Nov 16, 2009
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2009
16 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BETAXOLOL HYDROCHLORIDE
Strength
EQ 0.5% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 078694
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BETAXOLOL HYDROCHLORIDE
- 1989BETOPTIC SBrand (NDA)
NDA 019845 · NOVARTIS
- 1989KERLONEBrand (NDA)
NDA 019507 · SANOFI AVENTIS US
- 1985BETOPTICBrand (NDA)
NDA 019270 · SANDOZ
- 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.
