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    Pseudoephedrine Sulfate

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    01

    Ascent Innovative Medicines

    India
    Fi Europe 2024
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    Ascent Innovative Medicines

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    Loratadine; Pseudoephedrine Sulfate

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    Dosage Form : ER Tablet

    Dosage Strength : 5MG; 120MG

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    02

    Avanthi Pharma

    U.S.A
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    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG

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    Approval Date : 2013-02-27

    Application Number : 78648

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Avet Pharmaceuticals

    U.S.A
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    Regulatory Info : DISCN

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    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;120MG

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    Approval Date : 2004-01-28

    Application Number : 76208

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    Bayer AG

    Germany
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    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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    05

    Bayer AG

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    Regulatory Info : DISCN

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    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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    06

    Bayer AG

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    Regulatory Info : DISCN

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    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

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Bayer AG

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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

    Registration Country : USA

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    08

    Bayer AG

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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

    Regulatory Info : OTC

    Registration Country : USA

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    09

    Bayer AG

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    Regulatory Info : OTC

    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 : OTC

    Registration Country : Canada

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    10

    Bayer AG

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    Regulatory Info : OTC

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    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 : OTC

    Registration Country : Canada

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    11

    Bayer AG

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    Regulatory Info : OTC

    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 : OTC

    Registration Country : Canada

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    12

    Bayer AG

    Germany
    Fi Europe 2024
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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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    13

    Bionpharma

    U.S.A
    Fi Europe 2024
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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;240MG

    Packaging :

    Approval Date : 2024-05-14

    Application Number : 218017

    Regulatory Info : OTC

    Registration Country : USA

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    14

    Copley Scientific

    United Kingdom
    Fi Europe 2024
    Not Confirmed
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    Copley Scientific

    United Kingdom
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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : BROMPHERIL

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG

    Packaging :

    Approval Date : 1987-01-22

    Application Number : 89116

    Regulatory Info : DISCN

    Registration Country : USA

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    iNova Pharmaceuticals

    Singapore
    Fi Europe 2024
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    Singapore
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    Regulatory Info : Originator

    Registration Country : South Africa

    Pseudoephedrine sulphate

    Brand Name : Demazin ND

    Dosage Form : SRT

    Dosage Strength : 120mg

    Packaging : 6X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    16

    Merck & Co

    U.S.A
    Fi Europe 2024
    Not Confirmed
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    Merck & Co

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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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    17

    Merck & Co

    U.S.A
    Fi Europe 2024
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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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    19

    Merck & Co

    U.S.A
    Fi Europe 2024
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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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    Merck & Co

    U.S.A
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    Regulatory Info : Originator

    Registration Country : South Africa

    Pseudoephedrine Sulphate

    Brand Name : Proscar

    Dosage Form : TAB

    Dosage Strength : 120mg

    Packaging : 28X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Organon

    U.S.A
    Fi Europe 2024
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    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

    U.S.A
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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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    Perrigo Company plc

    Ireland
    Fi Europe 2024
    Not Confirmed
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    Ireland
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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;240MG

    Packaging :

    Approval Date : 2004-03-04

    Application Number : 75989

    Regulatory Info : OTC

    Registration Country : USA

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    24

    Perrigo Company plc

    Ireland
    Fi Europe 2024
    Not Confirmed
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    Perrigo Company plc

    Ireland
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    Fi Europe 2024
    Not Confirmed
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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;120MG

    Packaging :

    Approval Date : 2003-01-30

    Application Number : 76050

    Regulatory Info : OTC

    Registration Country : USA

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    25

    Pioneer Pharma

    Iraq
    Fi Europe 2024
    Not Confirmed
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    Pioneer Pharma

    Iraq
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    Fi Europe 2024
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Brand Name : RESPORAL

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG;120MG

    Packaging :

    Approval Date : 1988-06-16

    Application Number : 89139

    Regulatory Info : DISCN

    Registration Country : USA

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    26

    PL Developments

    U.S.A
    Fi Europe 2024
    Not Confirmed
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    PL Developments

    U.S.A
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    Fi Europe 2024
    Not Confirmed
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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;240MG

    Packaging :

    Approval Date : 2003-02-21

    Application Number : 75706

    Regulatory Info : OTC

    Registration Country : USA

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    27

    Sandoz B2B

    Switzerland
    Fi Europe 2024
    Not Confirmed
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    Sandoz B2B

    Switzerland
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    Fi Europe 2024
    Not Confirmed
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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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    28

    Sun Pharmaceutical Industries Limit...

    India
    Fi Europe 2024
    Not Confirmed
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    Sun Pharmaceutical Industries Limit...

    India
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    Fi Europe 2024
    Not Confirmed
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    Regulatory Info : OTC

    Registration Country : USA

    LORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : LORATADINE AND PSEUDOEPHEDRINE SULFATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;240MG

    Packaging :

    Approval Date : 2004-09-22

    Application Number : 76557

    Regulatory Info : OTC

    Registration Country : USA

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    29

    XYZ Pharma

    Gabon
    Fi Europe 2024
    Not Confirmed
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    XYZ Pharma

    Gabon
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    Fi Europe 2024
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    DESLORATADINE; PSEUDOEPHEDRINE SULFATE

    Brand Name : DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;240MG

    Packaging :

    Approval Date : 2011-04-26

    Application Number : 78366

    Regulatory Info : RX

    Registration Country : USA

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