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01 5Sanofi

02 1Acella Pharmaceuticals

03 1Actor Pharma

04 2Alcon Inc

05 1Apotex Inc

06 1Brooks laboratories Limited

07 2Epic Pharma. LLC.

08 1Farmak JSC

09 1Flagship Biotech International Pvt. Ltd

10 2KVK.Tech

11 1Laboratoires Alcon SA

12 1MEDIMETRIKS PHARMS

13 2Medius AG

14 1National Pharma

15 6Novartis Pharmaceuticals Australia Pty Limited

16 1Novartis Pharmaceuticals Corporation

17 3Novartis South Africa (Pty) Ltd

18 1PRO.MED.CS Praha

19 3S.A. Alcon-Couvreur N.V.

20 2SA Alcon Couvreur NV

21 1Sandoz B2B

22 1ScieGen Pharmaceuticals

23 1Velpharm

24 1World Medicine

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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.

Regulatory Info : DISCN

Registration Country : USA

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Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1989-10-27

Application Number : 19507

Regulatory Info : DISCN

Registration Country : USA

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.

Regulatory Info : DISCN

Registration Country : USA

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Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1989-10-27

Application Number : 19507

Regulatory Info : DISCN

Registration Country : USA

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.

Regulatory Info : DISCN

Registration Country : USA

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

Brand Name : KERLEDEX

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;12.5MG

Packaging :

Approval Date : 1992-10-30

Application Number : 19807

Regulatory Info : DISCN

Registration Country : USA

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.

Regulatory Info : DISCN

Registration Country : USA

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

Brand Name : KERLEDEX

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;12.5MG

Packaging :

Approval Date : 1992-10-30

Application Number : 19807

Regulatory Info : DISCN

Registration Country : USA

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : Italy

Betaxolol

Brand Name : Kerlon

Dosage Form : Betaxolol 20Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 20 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

06

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Packaging :

Approval Date : 2009-11-16

Application Number : 78694

Regulatory Info : RX

Registration Country : USA

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07

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

Brand Name : BETOPTIC PILO

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.25% BASE;1.75%

Packaging :

Approval Date : 1997-04-17

Application Number : 20619

Regulatory Info : DISCN

Registration Country : USA

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08

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

Betaxolol

Brand Name : Betoptic

Dosage Form : Betaxolol 5Mg/Ml 5Ml Solution Ophthalmic Use

Dosage Strength : EYE DROPS 5 ml 5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Packaging :

Approval Date : 2000-09-28

Application Number : 75446

Regulatory Info : DISCN

Registration Country : USA

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10

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

Betaxolol

Brand Name :

Dosage Form : Eye/Ear Drop

Dosage Strength : 0.5% W/V

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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11

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 1999-10-22

Application Number : 75541

Regulatory Info : RX

Registration Country : USA

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12

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 1999-10-22

Application Number : 75541

Regulatory Info : RX

Registration Country : USA

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14

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

Betaxolol

Brand Name :

Dosage Form : Eye Drops

Dosage Strength : 0.25% W/V

Packaging : 2.5ml/5ml/10/15ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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15

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2008-06-27

Application Number : 78962

Regulatory Info : RX

Registration Country : USA

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16

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2008-06-27

Application Number : 78962

Regulatory Info : RX

Registration Country : USA

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17

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Packaging :

Approval Date : 2001-04-12

Application Number : 75630

Regulatory Info : RX

Registration Country : USA

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18

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETOPTIC S

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.25% BASE

Packaging :

Approval Date : 1989-12-29

Application Number : 19845

Regulatory Info : RX

Registration Country : USA

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19

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

Betaxolol

Brand Name : Betaxolol PMCS

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Czech Republic

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20

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETOPTIC

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Packaging :

Approval Date : 1985-08-30

Application Number : 19270

Regulatory Info : RX

Registration Country : USA

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21

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

BETAXOLOL HYDROCHLORIDE

Brand Name : BETAXOLOL HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.5% BASE

Packaging :

Approval Date : 2000-06-30

Application Number : 75386

Regulatory Info : DISCN

Registration Country : USA

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22

OPRD USA
Not Confirmed
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OPRD USA
Not Confirmed

Betaxolol Hydrochloride

Brand Name : BETAKSIL

Dosage Form : EYE DROPS

Dosage Strength : 0.5%

Packaging : 5 ML/BOTTLE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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23

SA Alcon Couvreur NV

Country
OPRD USA
Not Confirmed
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SA Alcon Couvreur NV

Country
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OPRD USA
Not Confirmed

betaxolol hydrochloride

Brand Name : Betoptic

Dosage Form : EYE DROPS, SOLUTION

Dosage Strength : 5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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24

SA Alcon Couvreur NV

Country
OPRD USA
Not Confirmed
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SA Alcon Couvreur NV

Country
arrow
OPRD USA
Not Confirmed

betaxolol hydrochloride

Brand Name : Betoptic S

Dosage Form : EYE DROPS, SUSPENSION

Dosage Strength : 2.5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Laboratoires Alcon SA

Country
OPRD USA
Not Confirmed
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Laboratoires Alcon SA

Country
arrow
OPRD USA
Not Confirmed

betaxolol hydrochloride

Brand Name : Betoptic S

Dosage Form : EYE DROPS, SUSPENSION IN SINGLE-DOSE CONTAINERS

Dosage Strength : 2.5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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26

S.A. Alcon-Couvreur N.V.

Country
OPRD USA
Not Confirmed
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S.A. Alcon-Couvreur N.V.

Country
arrow
OPRD USA
Not Confirmed

Betaxolol

Brand Name : Betoptic

Dosage Form : Eye drops, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

27

S.A. Alcon-Couvreur N.V.

Country
OPRD USA
Not Confirmed
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S.A. Alcon-Couvreur N.V.

Country
arrow
OPRD USA
Not Confirmed

Betaxolol

Brand Name : Betoptic S

Dosage Form : Eye drops, suspension

Dosage Strength : 2.5 mg/ml

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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28

S.A. Alcon-Couvreur N.V.

Country
OPRD USA
Not Confirmed
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S.A. Alcon-Couvreur N.V.

Country
arrow
OPRD USA
Not Confirmed

Betaxolol

Brand Name : Betoptic S

Dosage Form : Eye drops, suspension

Dosage Strength : 2.5 mg/ml

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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29

Medius AG

Country
OPRD USA
Not Confirmed
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Medius AG

Country
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OPRD USA
Not Confirmed

Betaxololum

Brand Name : Betoptic S

Dosage Form : Gtt Opht

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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30

Medius AG

Country
OPRD USA
Not Confirmed
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Medius AG

Country
arrow
OPRD USA
Not Confirmed

Betaxololum

Brand Name : Betoptic S

Dosage Form : Gtt Opht

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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