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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    01 10Aspen Pharmacare Holdings

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    03 3ANDAS 5 HOLDING

    04 3Actavis Inc

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    06 3AiPing Pharmaceutical Inc

    07 2Alphapharm PTY Ltd

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    62 3Unichem Laboratories Limited

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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

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    Approval Date : 18/12/1981

    Application Number : 19811218000021

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Approved

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    Labetalol Hydrochloride

    Brand Name : Trandate

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    Approval Date : 18/12/1981

    Application Number : 19811218000038

    Regulatory Info : Approved

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    Regulatory Info : Approved

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    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 5mg/ml

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    Approval Date : 18/12/1981

    Application Number : 19811218000045

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Labetalol Hydrochloride

    Brand Name : Trandate

    Dosage Form : Injectable Solution

    Dosage Strength : 100mg/20ml

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    Approval Date : 23/10/1979

    Application Number : 41529

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    Labetalol Hydrochloride

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    Approval Date : 05/12/1978

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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

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    Labetalol Hydrochloride

    Brand Name : Trandate Injection

    Dosage Form : INJ

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    Packaging : 20X5mg/1ml

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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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    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

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    Registration Country : Denmark

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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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    11

    Alvogen

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    Regulatory Info : DISCN

    Registration Country : USA

    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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    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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    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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    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

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    15

    Bayer AG

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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

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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**

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    Approval Date : 1987-08-31

    Application Number : 18687

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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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    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 : 18687

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    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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