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    Approved Drug Products of Cheplapharm Arzneimittel Gmbh listed in the FDA Orange Book. Original Data : FDA Website

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    CHEPLAPHARM ARZNEIMITTEL GMBH

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    DOSSIERs // Finished Dosage Formulations

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    Cheplapharm Arzneimittel Gmbh
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    Country
    Country
    Germany
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    Address
    BAHNHOFSTR. 1A
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    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    https://www.cheplapharm.com/
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      CAPECITABINE

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      TABLET; ORAL
      150MG
      1998-04-30
      20896
      XELODA
      RX
      Yes
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        CAPECITABINE

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        TABLET; ORAL
        500MG
        1998-04-30
        20896
        XELODA
        RX
        Yes
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          CLONAZEPAM

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          TABLET; ORAL
          0.5MG
          1982-01-01
          17533
          KLONOPIN
          RX
          Yes
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            CLONAZEPAM

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            TABLET; ORAL
            1MG
            1982-01-01
            17533
            KLONOPIN
            RX
            Yes
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              CLONAZEPAM

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              TABLET; ORAL
              2MG
              1982-01-01
              17533
              KLONOPIN
              RX
              Yes
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                CLONAZEPAM

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                TABLET; ORAL
                0.125MG
                1997-04-09
                17533
                KLONOPIN
                DISCN
                No
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                  CLONAZEPAM

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                  TABLET; ORAL
                  0.25MG
                  1997-04-09
                  17533
                  KLONOPIN
                  DISCN
                  No
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                    ETOPOSIDE PHOSPHATE

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                    INJECTABLE; INJECT...
                    EQ 100MG BASE/VIAL
                    1996-05-17
                    20457
                    ETOPOPHOS PRESERVA...
                    RX
                    Yes
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                      GANCICLOVIR SODIUM

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                      INJECTABLE; INJECT...
                      EQ 500MG BASE/VIAL...
                      1989-06-23
                      19661
                      CYTOVENE
                      DISCN
                      Yes
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                        HYDROXYUREA

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                        CAPSULE; ORAL
                        500MG
                        1982-01-01
                        16295
                        HYDREA
                        RX
                        Yes
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                          HYDROXYUREA

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                          CAPSULE; ORAL
                          200MG
                          1998-02-25
                          16295
                          DROXIA
                          RX
                          Yes
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                            HYDROXYUREA

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                            CAPSULE; ORAL
                            300MG
                            1998-02-25
                            16295
                            DROXIA
                            RX
                            Yes
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                              HYDROXYUREA

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                              CAPSULE; ORAL
                              400MG
                              1998-02-25
                              16295
                              DROXIA
                              RX
                              Yes
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                                OLANZAPINE

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                                TABLET; ORAL
                                2.5MG
                                1996-09-30
                                20592
                                ZYPREXA
                                RX
                                Yes
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                                  OLANZAPINE

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                                  TABLET; ORAL
                                  5MG
                                  1996-09-30
                                  20592
                                  ZYPREXA
                                  RX
                                  Yes
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                                    OLANZAPINE

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                                    TABLET; ORAL
                                    7.5MG
                                    1996-09-30
                                    20592
                                    ZYPREXA
                                    RX
                                    Yes
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                                      OLANZAPINE

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                                      TABLET; ORAL
                                      10MG
                                      1996-09-30
                                      20592
                                      ZYPREXA
                                      RX
                                      Yes
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                                        OLANZAPINE

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                                        TABLET; ORAL
                                        15MG
                                        1997-09-09
                                        20592
                                        ZYPREXA
                                        RX
                                        Yes
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                                          OLANZAPINE

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                                          TABLET; ORAL
                                          20MG
                                          1997-09-09
                                          20592
                                          ZYPREXA
                                          RX
                                          Yes
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                                            OLANZAPINE

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                                            TABLET, ORALLY DIS...
                                            5MG
                                            2000-04-06
                                            21086
                                            ZYPREXA ZYDIS
                                            RX
                                            Yes
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                                              OLANZAPINE

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                                              TABLET, ORALLY DIS...
                                              10MG
                                              2000-04-06
                                              21086
                                              ZYPREXA ZYDIS
                                              RX
                                              Yes
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                                                OLANZAPINE

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                                                TABLET, ORALLY DIS...
                                                15MG
                                                2000-04-06
                                                21086
                                                ZYPREXA ZYDIS
                                                RX
                                                Yes
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                                                  OLANZAPINE

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                                                  TABLET, ORALLY DIS...
                                                  20MG
                                                  2000-04-06
                                                  21086
                                                  ZYPREXA ZYDIS
                                                  RX
                                                  Yes
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                                                    OLANZAPINE

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                                                    INJECTABLE; INTRAM...
                                                    10MG/VIAL
                                                    2004-03-29
                                                    21253
                                                    ZYPREXA
                                                    RX
                                                    Yes
                                                    AP
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                                                      OLANZAPINE PAMOATE

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                                                      SUSPENSION, EXTEND...
                                                      EQ 210MG BASE/VIAL
                                                      2009-12-11
                                                      22173
                                                      ZYPREXA RELPREVV
                                                      RX
                                                      Yes
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                                                        OLANZAPINE PAMOATE

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                                                        SUSPENSION, EXTEND...
                                                        EQ 300MG BASE/VIAL
                                                        2009-12-11
                                                        22173
                                                        ZYPREXA RELPREVV
                                                        RX
                                                        Yes
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                                                          OLANZAPINE PAMOATE

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                                                          SUSPENSION, EXTEND...
                                                          EQ 405MG BASE/VIAL
                                                          2009-12-11
                                                          22173
                                                          ZYPREXA RELPREVV
                                                          RX
                                                          Yes
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                                                            ORLISTAT

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                                                            CAPSULE; ORAL
                                                            120MG
                                                            1999-04-23
                                                            20766
                                                            XENICAL
                                                            RX
                                                            Yes
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                                                              TRETINOIN

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                                                              CAPSULE; ORAL
                                                              10MG **Federal Reg...
                                                              1995-11-22
                                                              20438
                                                              VESANOID
                                                              DISCN
                                                              Yes
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                                                                VALGANCICLOVIR HYDROCHLORIDE

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                                                                TABLET; ORAL
                                                                EQ 450MG BASE
                                                                2001-03-29
                                                                21304
                                                                VALCYTE
                                                                RX
                                                                Yes
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                                                                  VALGANCICLOVIR HYDROCHLORIDE

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                                                                  FOR SOLUTION; ORAL
                                                                  50MG/ML
                                                                  2009-08-28
                                                                  22257
                                                                  VALCYTE
                                                                  RX
                                                                  Yes
                                                                  AB
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