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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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    Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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    Labetalol Hydrochloride

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    01

    Aspen Pharmacare Holdings

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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 : 19811218000021

    Regulatory Info : Approved

    Registration Country : Sweden

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    Aspen Pharmacare Holdings

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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 : 19811218000038

    Regulatory Info : Approved

    Registration Country : Sweden

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    Aspen Pharmacare Holdings

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    Regulatory Info : Approved

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    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 5mg/ml

    Packaging :

    Approval Date : 18/12/1981

    Application Number : 19811218000045

    Regulatory Info : Approved

    Registration Country : Sweden

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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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    Aspen Pharmacare Holdings

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05/12/1978

    Application Number : 41530

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Aspen Pharmacare Holdings

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    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 : Originator

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    Labetalol Hydrochloride

    Brand Name : Trandate Injection

    Dosage Form : INJ

    Dosage Strength : 5mg/1ml

    Packaging : 20X5mg/1ml

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    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**

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    Approval Date : 1985-05-24

    Application Number : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Alvogen

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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG **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 : 18716

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    Registration Country : USA

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    10

    Alvogen

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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG **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 : 18716

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    11

    Alvogen

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    Regulatory Info : DISCN

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    LABETALOL HYDROCHLORIDE

    Brand Name : TRANDATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 400MG **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 : 18716

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Bayer AG

    Germany
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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**

    Packaging :

    Approval Date : 1984-08-01

    Application Number : 18686

    Regulatory Info : DISCN

    Registration Country : USA

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    Bayer AG

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    Regulatory Info : DISCN

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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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    Regulatory Info : DISCN

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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**

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    Approval Date : 1984-08-01

    Application Number : 18687

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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**

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    Approval Date : 1984-08-01

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    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**

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    Approval Date : 1984-08-01

    Application Number : 18687

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;100MG

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    Approval Date : 1987-04-06

    Application Number : 19046

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;200MG

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    Approval Date : 1987-04-06

    Application Number : 19046

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;300MG

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    Approval Date : 1987-04-06

    Application Number : 19046

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    HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

    Brand Name : NORMOZIDE

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    Dosage Strength : 25MG;400MG

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    Approval Date : 1987-04-06

    Application Number : 19046

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