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    Approved Drug Products containing Pseudoephedrine Sulfate listed in the FDA Orange Book. Original Data : FDA Website

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    Pseudoephedrine Sulfate

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    01 AVANTHI INC (1)

    02 BAYER HEALTHCARE LLC (3)

    03 COPLEY PHARM (1)

    04 DR REDDYS LABS LTD (1)

    05 HERITAGE PHARMA (1)

    06 ORGANON (1)

    07 ORGANON LLC (1)

    08 P AND L (1)

    09 PERRIGO PHARMA INTL (2)

    10 PIONEER PHARMS (1)

    11 SANDOZ (1)

    12 SCHERING (2)

    13 SCHERING PLOUGH (4)

    14 SUN PHARM INDS LTD (1)

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    01 TABLET, EXTENDED RELEASE;ORAL (20)

    02 TABLET;ORAL (1)

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    01 DISCN (13)

    02 OTC (6)

    03 RX (2)

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    01 AFRINOL (1)

    02 BROMPHERIL (1)

    03 CHLOR-TRIMETON (1)

    04 CLARINEX D 24 HOUR (1)

    05 CLARINEX-D 12 HOUR (1)

    06 CLARITIN-D (1)

    07 CLARITIN-D 24 HOUR (1)

    08 DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (1)

    09 DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (1)

    10 DISOBROM (1)

    11 DISOPHROL (2)

    12 DRIXORAL (1)

    13 DRIXORAL PLUS (1)

    14 LORATADINE AND PSEUDOEPHEDRINE SULFATE (5)

    15 RESPORAL (1)

    16 TRINALIN (1)

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    01 No (14)

    02 Yes (7)

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    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    PDF Supplier PDF
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    TABLET;ORAL
    2MG;60MG
    1982-01-01
    12394
    DISOPHROL
    DISCN
    No
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    BAYER HEALTHCARE LLC

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    CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    PDF Supplier PDF
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    TABLET, EXTENDED RELEASE;ORAL
    8MG;120MG
    1982-01-01
    18397
    CHLOR-TRIMETON
    DISCN
    Yes
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    SCHERING

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    AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    1MG;120MG
    1982-03-23
    18506
    TRINALIN
    DISCN
    No
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    BAYER HEALTHCARE LLC

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    LORATADINE; PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    5MG;120MG
    2002-11-27
    19670
    CLARITIN-D
    OTC
    Yes
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    BAYER HEALTHCARE LLC

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    LORATADINE; PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    10MG;240MG
    2002-11-27
    20470
    CLARITIN-D 24 HOUR
    OTC
    Yes
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    SCHERING PLOUGH

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    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    1982-09-13
    13483
    DRIXORAL
    DISCN
    Yes
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    DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET, EXTENDED RELEASE;ORAL
    6MG;120MG
    1982-09-13
    13483
    DISOPHROL
    DISCN
    No
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    SCHERING PLOUGH

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    PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    120MG
    1982-01-01
    18191
    AFRINOL
    DISCN
    Yes
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    SCHERING PLOUGH

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    ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

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    TABLET, EXTENDED RELEASE;ORAL
    500MG;3MG;60MG
    1987-05-22
    19453
    DRIXORAL PLUS
    DISCN
    No
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    ORGANON LLC

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      DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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      TABLET, EXTENDED RELEASE;ORAL
      2.5MG;120MG
      2006-02-01
      21313
      CLARINEX-D 12 HOUR
      RX
      Yes
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