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Approved Drug Products containing Betaxolol listed in the FDA Orange Book. Original Data : FDA Website

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01 SANOFI AVENTIS US (4)

02 ACELLA (1)

03 AKORN (1)

04 ALCON (1)

05 APOTEX INC (1)

06 EPIC PHARMA (2)

07 KVK TECH (2)

08 MEDIMETRIKS PHARMS (1)

09 NOVARTIS (1)

10 SANDOZ (1)

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01 SOLUTION/DROPS;OPHTHALMIC (5)

02 SUSPENSION/DROPS;OPHTHALMIC (2)

03 TABLET;ORAL (8)

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01 DISCN (7)

02 RX (8)

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01 BETAXOLOL HYDROCHLORIDE (8)

02 BETOPTIC (1)

03 BETOPTIC PILO (1)

04 BETOPTIC S (1)

05 KERLEDEX (2)

06 KERLONE (2)

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01 No (13)

02 Yes (2)

URL Supplier Web Content
TABLET;ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1989-10-27
19507
KERLONE
DISCN
No
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1989-10-27
19507
KERLONE
DISCN
No
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
5MG;12.5MG
1992-10-30
19807
KERLEDEX
DISCN
No
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
10MG;12.5MG
1992-10-30
19807
KERLEDEX
DISCN
No
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
EQ 0.5% BASE
2000-06-30
75386
BETAXOLOL HYDROCHLORID...
DISCN
No
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SUSPENSION/DROPS;OPHTHALMIC
EQ 0.25% BASE;1.75%
1997-04-17
20619
BETOPTIC PILO
DISCN
No
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SOLUTION/DROPS;OPHTHALMIC
EQ 0.5% BASE
2000-09-28
75446
BETAXOLOL HYDROCHLORID...
DISCN
No
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TABLET;ORAL
10MG
1999-10-22
75541
BETAXOLOL HYDROCHLORID...
RX
No
AB
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SUSPENSION/DROPS;OPHTHALMIC
EQ 0.25% BASE
1989-12-29
19845
BETOPTIC S
RX
Yes
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SOLUTION/DROPS;OPHTHALMIC
EQ 0.5% BASE
1985-08-30
19270
BETOPTIC
RX
Yes
AT
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