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

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01 4SANOFI AVENTIS US

02 1ACELLA

03 1ALCON

04 1APOTEX INC

05 2EPIC PHARMA

06 2KVK TECH

07 1MEDIMETRIKS PHARMS

08 1NOVARTIS

09 1SANDOZ

10 1SCIEGEN PHARMS INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

BETAXOLOL HYDROCHLORIDE

Brand Name : KERLONE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1989-10-27

Application Number : 19507

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

BETAXOLOL HYDROCHLORIDE

Brand Name : KERLONE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1989-10-27

Application Number : 19507

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

Brand Name : KERLEDEX

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;12.5MG

Approval Date : 1992-10-30

Application Number : 19807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

Brand Name : KERLEDEX

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;12.5MG

Approval Date : 1992-10-30

Application Number : 19807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

05

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BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

Brand Name : BETOPTIC PILO

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.25% BASE;1.75%

Approval Date : 1997-04-17

Application Number : 20619

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

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BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Approval Date : 2000-09-28

Application Number : 75446

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1999-10-22

Application Number : 75541

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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BETAXOLOL HYDROCHLORIDE

Brand Name : BETOPTIC S

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.25% BASE

Approval Date : 1989-12-29

Application Number : 19845

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

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BETAXOLOL HYDROCHLORIDE

Brand Name : BETOPTIC

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Approval Date : 1985-08-30

Application Number : 19270

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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10

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BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Approval Date : 2000-06-30

Application Number : 75386

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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