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    Labetalol Hydrochloride

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    Aspen Pharmacare Holdings

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 100mg/20ml

    Packaging :

    Approval Date : 23/10/1979

    Application Number : 41529

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 1984-08-01

    Application Number : 18686

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : Allowed

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    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Tablet

    Dosage Strength : 100mg

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    Approval Date : 05/12/1978

    Application Number : 41530

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Allowed

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    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Tablet

    Dosage Strength : 200mg

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    Approval Date : 05/12/1978

    Application Number : 41530

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 28-06-1978

    Application Number : 28100699976

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Aspen Pharmacare Holdings

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 200mg

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    Approval Date : 28-06-1978

    Application Number : 28100954976

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Regulatory Info : Prescription

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    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injection Solution

    Dosage Strength : 5mg/ml

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    Approval Date : 11-01-1982

    Application Number : 28100700076

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 18-12-1981

    Application Number : 1.98E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Film Coated Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 18-12-1981

    Application Number : 1.98E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    10

    Aspen Pharmacare Holdings

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    Regulatory Info : Approved

    Registration Country : Sweden

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 5mg/ml

    Packaging :

    Approval Date : 18-12-1981

    Application Number : 1.98E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    Aspen Pharmacare Holdings

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    Regulatory Info : Originator

    Registration Country : South Africa

    Labetalol Hydrochloride

    Brand Name : Trandate Injection

    Dosage Form : INJ

    Dosage Strength : 5mg/1ml

    Packaging : 20X5mg/1ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    12

    Bayer AG

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1987-08-31

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Bayer AG

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Bayer AG

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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    Bayer AG

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    LABETALOL HYDROCHLORIDE

    Brand Name : NORMODYNE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18687

    Regulatory Info : DISCN

    Registration Country : USA

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    16

    Bayer AG

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;100MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    17

    Bayer AG

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;200MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Bayer AG

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;300MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Bayer AG

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;400MG

    Packaging :

    Approval Date : 1987-04-06

    Application Number : 19046

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    Alvogen

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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1985-05-24

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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