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    Pseudoephedrine Sulfate

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    Bayer AG

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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DISOPHROL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 2MG;60MG

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    Approval Date : 1982-01-01

    Application Number : 12394

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : DISCN

    Registration Country : USA

    CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : CHLOR-TRIMETON

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 8MG;120MG

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    Approval Date : 1982-01-01

    Application Number : 18397

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : DISCN

    Registration Country : USA

    AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : TRINALIN

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 1MG;120MG

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    Approval Date : 1982-03-23

    Application Number : 18506

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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARITIN-D

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;120MG

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    Approval Date : 2002-11-27

    Application Number : 19670

    Regulatory Info : OTC

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    Regulatory Info : OTC

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    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARITIN-D 24 HOUR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;240MG

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    Approval Date : 2002-11-27

    Application Number : 20470

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    Regulatory Info : Authorised

    Registration Country : Malta

    Loratadine; Pseudoephedrine Sulfate

    Brand Name : Clarinase Repetabs

    Dosage Form : Prolonged-Release Tablet

    Dosage Strength : 5MG; 120MG

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    Approval Date : 2007-01-02

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    Regulatory Info : Authorised

    Registration Country : Malta

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    Regulatory Info : Cancelled

    Registration Country : Spain

    Paracetamol; Pseudoephedrine Sulfate; Dextromethorphan Hydrobromide

    Brand Name : Larobeta

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 500MG; 30MG; 15 MG

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    Approval Date : 15-04-2012

    Application Number : 75767

    Regulatory Info : Cancelled

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Pseudoephedrine Sulfate; Loratadine

    Brand Name : Clarityne Plus

    Dosage Form : Extended-Release Tablet

    Dosage Strength : 10MG; 240MG

    Packaging :

    Approval Date : 26-10-2000

    Application Number : 63423

    Regulatory Info : Authorized

    Registration Country : Spain

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    09

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    Regulatory Info : Authorized

    Registration Country : Spain

    Pseudoephedrine Sulfate; Loratadine

    Brand Name : Narine Repetabs

    Dosage Form : Extended-Release Tablet

    Dosage Strength : 5MG; 120 MG

    Packaging :

    Approval Date : 01-10-1992

    Application Number : 59556

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARITIN ALLERGY + SINUS

    Dosage Form : TABLET (IMMEDIATE AND EXTENDED RELEASE)

    Dosage Strength : 120MG

    Packaging : 10/20/30

    Approval Date :

    Application Number : 1945157

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARITIN ALLERGY + SINUS EXTRA STRENGTH

    Dosage Form : TABLET (IMMEDIATE AND EXTENDED RELEASE)

    Dosage Strength : 240MG

    Packaging : 1/2/5/10/15

    Approval Date :

    Application Number : 2260557

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    12

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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    PSEUDOEPHEDRINE SULFATE

    Brand Name : AERIUS SINUS + ALLERGY

    Dosage Form : TABLET (EXTENDED-RELEASE)

    Dosage Strength : 120MG

    Packaging : 2/4/7/10/14/20/30

    Approval Date :

    Application Number : 2309300

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    13

    Bayer AG

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    Regulatory Info : Originator

    Registration Country : South Africa

    Pseudoephedrine sulphate

    Brand Name : Clarityne Plus Repetabs

    Dosage Form : SRT

    Dosage Strength : 120mg

    Packaging : 6X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    14

    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DRIXORAL

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1982-09-13

    Application Number : 13483

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    Merck & Co

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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DISOPHROL

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG

    Packaging :

    Approval Date : 1982-09-13

    Application Number : 13483

    Regulatory Info : DISCN

    Registration Country : USA

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    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    PSEUDOEPHEDRINE SULFATE

    Brand Name : AFRINOL

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 120MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 18191

    Regulatory Info : DISCN

    Registration Country : USA

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    Merck & Co

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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DRIXORAL PLUS

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 500MG;3MG;60MG

    Packaging :

    Approval Date : 1987-05-22

    Application Number : 19453

    Regulatory Info : DISCN

    Registration Country : USA

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    Organon

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    DESLORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARINEX-D 12 HOUR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 2.5MG;120MG

    Packaging :

    Approval Date : 2006-02-01

    Application Number : 21313

    Regulatory Info : RX

    Registration Country : USA

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    Organon

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    Regulatory Info : DISCN

    Registration Country : USA

    DESLORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : CLARINEX D 24 HOUR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 2005-03-03

    Application Number : 21605

    Regulatory Info : DISCN

    Registration Country : USA

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    Sandoz B2B

    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DISOBROM

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG

    Packaging :

    Approval Date : 1991-09-30

    Application Number : 70770

    Regulatory Info : DISCN

    Registration Country : USA

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