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    EURAND
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    U.S.A
    Address
    Address
    Morris Corporate Center III
    Telephone
    Telephone
    +1 (862) 261-7000
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    enquiries@pharmacompass.com
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    http://www.aptalispharma.com
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      Aspirin

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      USDMF

      Caution USDMF

      8053
      Inactive
      ASPIRIN EC-2 (MICROENCAPSULATED)
      1989-05-05
      CEP/COS

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      Japanese DMF

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      Written Confirmation

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      Application Number
      8053
      Status
      Inactive
      Fees Unpaid
      N/A
       
      Filing Details
      ASPIRIN EC-2 (MICROENCAPSULATED)
      Issue/Submission Date
      1989-05-05
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        Caffeine

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        USDMF

        Caution USDMF

        10643
        Inactive
        CAFFEINE MICROCAPS
        1993-12-30
        CEP/COS

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        Japanese DMF

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        Written Confirmation

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        Application Number
        10643
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        CAFFEINE MICROCAPS
        Issue/Submission Date
        1993-12-30
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          Cimetidine

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          USDMF

          Caution USDMF

          7234
          Inactive
          CIMETIDINE BASE MICROCAPSULES
          1987-11-17
          CEP/COS

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          Japanese DMF

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          Written Confirmation

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          Application Number
          7234
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          CIMETIDINE BASE MICROCAPSULES
          Issue/Submission Date
          1987-11-17
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            Cimetidine

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            USDMF

            Caution USDMF

            12361
            Inactive
            MICROCAPS CIMETIDINE, USP
            1997-01-31
            CEP/COS

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            Japanese DMF

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            Written Confirmation

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            Application Number
            12361
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MICROCAPS CIMETIDINE, USP
            Issue/Submission Date
            1997-01-31
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              Diphenhydramine Citrate

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              USDMF

              Caution USDMF

              12360
              Inactive
              DIPHENHYDRAMINE CITRATE (MICROCAPS)
              1997-01-31
              CEP/COS

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              Application Number
              12360
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              DIPHENHYDRAMINE CITRATE (MICROCAPS)
              Issue/Submission Date
              1997-01-31
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                Phenylpropanolamine

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                USDMF

                Caution USDMF

                12202
                Inactive
                MICROCAPS PHENYLPROPANOLAMINE HC1, ...
                1996-10-25
                CEP/COS

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                Japanese DMF

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                Written Confirmation

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                Application Number
                12202
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                MICROCAPS PHENYLPROPANOLAMINE HC1, ...
                Issue/Submission Date
                1996-10-25
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                  Potassium Chloride

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                  USDMF

                  Caution USDMF

                  8996
                  Inactive
                  POTASSIUM CHLORIDE MICROCAPS COMPRE...
                  1991-02-25
                  CEP/COS

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                  Japanese DMF

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                  Application Number
                  8996
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  POTASSIUM CHLORIDE MICROCAPS COMPRE...
                  Issue/Submission Date
                  1991-02-25
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                    Prazosin Hydrochloride

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                    USDMF

                    Caution USDMF

                    7032
                    Inactive
                    PRAZOSIN HYDROCHLORIDE CONTROLLED R...
                    1987-06-17
                    CEP/COS

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                    Japanese DMF

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                    Written Confirmation

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                    Application Number
                    7032
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    PRAZOSIN HYDROCHLORIDE CONTROLLED R...
                    Issue/Submission Date
                    1987-06-17
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                      Pseudoephedrine

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                      USDMF

                      Caution USDMF

                      15590
                      Inactive
                      DIFFUCAPS PSEUDOEPHEDRINE HCL BULK ...
                      2001-08-10
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      15590
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      DIFFUCAPS PSEUDOEPHEDRINE HCL BULK ...
                      Issue/Submission Date
                      2001-08-10
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                        Pseudoephedrine Hydrochloride

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                        USDMF

                        Caution USDMF

                        11665
                        Inactive
                        MICROCAPS PSEUDOEPHEDRINE HCL
                        1995-09-15
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        11665
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        MICROCAPS PSEUDOEPHEDRINE HCL
                        Issue/Submission Date
                        1995-09-15
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                          Pseudoephedrine Hydrochloride

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                          USDMF

                          Caution USDMF

                          12134
                          Inactive
                          PSEUDOEPHEDRINE HCL (MICROCAP)
                          1996-09-13
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          12134
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                           
                          Filing Details
                          PSEUDOEPHEDRINE HCL (MICROCAP)
                          Issue/Submission Date
                          1996-09-13
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                            Sulfamethoxazole

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                            USDMF

                            Caution USDMF

                            8211
                            Inactive
                            MICROENCAPSULATED SULFAMETHOXAZOLE
                            1989-09-01
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            8211
                            Status
                            Inactive
                            Fees Unpaid
                            N/A
                             
                            Filing Details
                            MICROENCAPSULATED SULFAMETHOXAZOLE
                            Issue/Submission Date
                            1989-09-01
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                              Trichlorfon

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                              USDMF

                              Caution USDMF

                              753
                              Inactive
                              TRICHLORFON IN SWINE (INJECTABLE) (...
                              1963-12-06
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              753
                              Status
                              Inactive
                              Fees Unpaid
                              N/A
                               
                              Filing Details
                              TRICHLORFON IN SWINE (INJECTABLE) (...
                              Issue/Submission Date
                              1963-12-06
                              ASK
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                                TENIACIDE IN DOGS, MICE AND CATS (VET)

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                                USDMF

                                Caution USDMF

                                754
                                Inactive
                                TENIACIDE IN DOGS, MICE AND CATS (...
                                1963-12-06
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                754
                                Status
                                Inactive
                                Fees Unpaid
                                N/A
                                 
                                Filing Details
                                TENIACIDE IN DOGS, MICE AND CATS (...
                                Issue/Submission Date
                                1963-12-06
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                                  RENACIDEN IN DOGS AND CATS (VET)

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                                  USDMF

                                  Caution USDMF

                                  756
                                  Inactive
                                  RENACIDEN IN DOGS AND CATS (VET)
                                  1963-12-03
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  756
                                  Status
                                  Inactive
                                  Fees Unpaid
                                  N/A
                                   
                                  Filing Details
                                  RENACIDEN IN DOGS AND CATS (VET)
                                  Issue/Submission Date
                                  1963-12-03
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                                    DYREX INJECTABLE IN SWINE AND HORSES (VET)

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                                    USDMF

                                    Caution USDMF

                                    757
                                    Inactive
                                    DYREX INJECTABLE IN SWINE AND HORSE...
                                    1963-12-09
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    757
                                    Status
                                    Inactive
                                    Fees Unpaid
                                    N/A
                                     
                                    Filing Details
                                    DYREX INJECTABLE IN SWINE AND HORSE...
                                    Issue/Submission Date
                                    1963-12-09
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                                      ENCAPSULATION

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                                      USDMF

                                      Caution USDMF

                                      927
                                      Inactive
                                      ENCAPSULATION
                                      1965-12-08
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      927
                                      Status
                                      Inactive
                                      Fees Unpaid
                                      N/A
                                       
                                      Filing Details
                                      ENCAPSULATION
                                      Issue/Submission Date
                                      1965-12-08
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                                        MICROENCAPSULATION PROCEDURE

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                                        USDMF

                                        Caution USDMF

                                        2105
                                        Inactive
                                        MICROENCAPSULATION PROCEDURE
                                        1973-05-16
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        2105
                                        Status
                                        Inactive
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        MICROENCAPSULATION PROCEDURE
                                        Issue/Submission Date
                                        1973-05-16
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                                          MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                                          USDMF

                                          Caution USDMF

                                          2704
                                          Inactive
                                          MANUFACTURING SITE, FACILITIES, PER...
                                          1976-06-15
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          2704
                                          Status
                                          Inactive
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          MANUFACTURING SITE, FACILITIES, PER...
                                          Issue/Submission Date
                                          1976-06-15
                                          ASK
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                                            MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                                            USDMF

                                            Caution USDMF

                                            5474
                                            Inactive
                                            MANUFACTURING SITE, FACILITIES, PER...
                                            1984-08-08
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            5474
                                            Status
                                            Inactive
                                            Fees Unpaid
                                            N/A
                                             
                                            Filing Details
                                            MANUFACTURING SITE, FACILITIES, PER...
                                            Issue/Submission Date
                                            1984-08-08
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                                              DIFFUTAB SIMETRY BASE

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                                              USDMF

                                              Caution USDMF

                                              8496
                                              Inactive
                                              DIFFUTAB SIMETRY BASE
                                              1990-03-29
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              8496
                                              Status
                                              Inactive
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              DIFFUTAB SIMETRY BASE
                                              Issue/Submission Date
                                              1990-03-29
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                                                PANCRELIPASE (ULTRASE) MINITABS

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                                                USDMF

                                                Caution USDMF

                                                10883
                                                Inactive
                                                PANCRELIPASE (ULTRASE) MINITABS
                                                1994-04-19
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                10883
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                 
                                                Filing Details
                                                PANCRELIPASE (ULTRASE) MINITABS
                                                Issue/Submission Date
                                                1994-04-19
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                                                  DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS

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                                                  USDMF

                                                  Caution USDMF

                                                  11843
                                                  Inactive
                                                  DIFFUCAPS PSEUDOEPHEDRINE HCL BULK ...
                                                  1996-02-05
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  11843
                                                  Status
                                                  Inactive
                                                  Fees Unpaid
                                                  N/A
                                                   
                                                  Filing Details
                                                  DIFFUCAPS PSEUDOEPHEDRINE HCL BULK ...
                                                  Issue/Submission Date
                                                  1996-02-05
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                                                    EUR-1084 ORALLY DISINTEGRATING TABLETS

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                                                    USDMF

                                                    Caution USDMF

                                                    22600
                                                    Inactive
                                                    EUR-1084 ORALLY DISINTEGRATING TABL...
                                                    2009-03-06
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    22600
                                                    Status
                                                    Inactive
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Filing Details
                                                    EUR-1084 ORALLY DISINTEGRATING TABL...
                                                    Issue/Submission Date
                                                    2009-03-06
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