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    Approved Drug Products of ROXANE listed in the FDA Orange Book. Original Data : FDA Website

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    ROXANE
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    P.O. Box 16532, Columbus, OH 43216
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    +1-800-962-8364
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      ACETAMINOPHEN; CODEINE PHOSPHATE

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      TABLET; ORAL
      300MG;30MG
      1982-01-01
      84656
      ACETAMINOPHEN AND ...
      DISCN
      No
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        ACETAMINOPHEN; CODEINE PHOSPHATE

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        TABLET; ORAL
        300MG;15MG
        1982-01-01
        84659
        ACETAMINOPHEN AND ...
        DISCN
        No
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          ACETAMINOPHEN; CODEINE PHOSPHATE

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          TABLET; ORAL
          300MG;60MG
          1982-01-01
          84667
          ACETAMINOPHEN AND ...
          DISCN
          No
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            ACETAMINOPHEN; CODEINE PHOSPHATE

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            TABLET; ORAL
            500MG;15MG
            1989-04-25
            89511
            ACETAMINOPHEN AND ...
            DISCN
            No
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              ACETAMINOPHEN; CODEINE PHOSPHATE

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              TABLET; ORAL
              500MG;30MG
              1989-04-25
              89512
              ACETAMINOPHEN AND ...
              DISCN
              No
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                ACETAMINOPHEN; CODEINE PHOSPHATE

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                TABLET; ORAL
                500MG;60MG
                1989-04-25
                89513
                ACETAMINOPHEN AND ...
                DISCN
                No
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                  ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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                  CAPSULE; ORAL
                  500MG;5MG
                  1995-07-03
                  40061
                  ROXILOX
                  DISCN
                  No
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                    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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                    TABLET; ORAL
                    500MG;5MG
                    1989-01-12
                    89775
                    ROXICET 5/500
                    DISCN
                    No
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                      ACETYLCYSTEINE

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                      SOLUTION; INHALATI...
                      10%
                      1992-04-30
                      72323
                      ACETYLCYSTEINE
                      DISCN
                      No
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                        ACETYLCYSTEINE

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                        SOLUTION; INHALATI...
                        20%
                        1992-04-30
                        72324
                        ACETYLCYSTEINE
                        DISCN
                        No
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                          ACETYLCYSTEINE

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                          SOLUTION; INHALATI...
                          10%
                          1992-09-30
                          72621
                          ACETYLCYSTEINE
                          DISCN
                          No
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                            ACETYLCYSTEINE

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                            SOLUTION; INHALATI...
                            20%
                            1992-09-30
                            72622
                            ACETYLCYSTEINE
                            DISCN
                            No
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                              ACYCLOVIR

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                              CAPSULE; ORAL
                              200MG
                              1997-04-22
                              74570
                              ACYCLOVIR
                              DISCN
                              No
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                                ALBUTEROL SULFATE

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                                SOLUTION; INHALATI...
                                EQ 0.083% BASE
                                2001-02-13
                                75129
                                ALBUTEROL SULFATE
                                DISCN
                                No
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                                  ALPRAZOLAM

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                                  TABLET; ORAL
                                  0.25MG
                                  1993-10-19
                                  74199
                                  ALPRAZOLAM
                                  DISCN
                                  No
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                                    ALPRAZOLAM

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                                    TABLET; ORAL
                                    0.5MG
                                    1993-10-19
                                    74199
                                    ALPRAZOLAM
                                    DISCN
                                    No
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                                      ALPRAZOLAM

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                                      TABLET; ORAL
                                      1MG
                                      1993-10-19
                                      74199
                                      ALPRAZOLAM
                                      DISCN
                                      No
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                                        ALPRAZOLAM

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                                        SOLUTION; ORAL
                                        0.5MG/5ML
                                        1993-10-31
                                        74314
                                        ALPRAZOLAM
                                        DISCN
                                        No
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                                          AMINOPHYLLINE

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                                          TABLET; ORAL
                                          100MG
                                          1982-02-09
                                          87500
                                          AMINOPHYLLINE
                                          DISCN
                                          No
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                                            AMINOPHYLLINE

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                                            TABLET; ORAL
                                            200MG
                                            1982-02-09
                                            87501
                                            AMINOPHYLLINE
                                            DISCN
                                            No
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                                              AMINOPHYLLINE

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                                              SOLUTION; ORAL
                                              105MG/5ML
                                              1983-08-19
                                              88126
                                              AMINOPHYLLINE
                                              DISCN
                                              No
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                                                AMITRIPTYLINE HYDROCHLORIDE

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                                                TABLET; ORAL
                                                25MG
                                                1982-01-01
                                                85944
                                                AMITRIPTYLINE HYDR...
                                                DISCN
                                                No
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                                                  AMITRIPTYLINE HYDROCHLORIDE

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                                                  TABLET; ORAL
                                                  50MG
                                                  1982-01-01
                                                  85945
                                                  AMITRIPTYLINE HYDR...
                                                  DISCN
                                                  No
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                                                    AMITRIPTYLINE HYDROCHLORIDE

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                                                    TABLET; ORAL
                                                    10MG
                                                    1982-01-01
                                                    86002
                                                    AMITRIPTYLINE HYDR...
                                                    DISCN
                                                    No
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                                                      AMITRIPTYLINE HYDROCHLORIDE

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                                                      TABLET; ORAL
                                                      100MG
                                                      1982-01-01
                                                      86003
                                                      AMITRIPTYLINE HYDR...
                                                      DISCN
                                                      No
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                                                        AMITRIPTYLINE HYDROCHLORIDE

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                                                        TABLET; ORAL
                                                        75MG
                                                        1982-01-01
                                                        86004
                                                        AMITRIPTYLINE HYDR...
                                                        DISCN
                                                        No
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                                                          AMITRIPTYLINE HYDROCHLORIDE

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                                                          TABLET; ORAL
                                                          150MG
                                                          1982-01-01
                                                          86090
                                                          AMITRIPTYLINE HYDR...
                                                          DISCN
                                                          No
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                                                            AMITRIPTYLINE HYDROCHLORIDE

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                                                            TABLET; ORAL
                                                            50MG
                                                            1982-01-01
                                                            86143
                                                            AMITRIPTYLINE HYDR...
                                                            DISCN
                                                            No
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                                                              AMITRIPTYLINE HYDROCHLORIDE

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                                                              TABLET; ORAL
                                                              10MG
                                                              1982-01-01
                                                              86144
                                                              AMITRIPTYLINE HYDR...
                                                              DISCN
                                                              No
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                                                                AMITRIPTYLINE HYDROCHLORIDE

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                                                                TABLET; ORAL
                                                                25MG
                                                                1982-01-01
                                                                86145
                                                                AMITRIPTYLINE HYDR...
                                                                DISCN
                                                                No
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                                                                  AMITRIPTYLINE HYDROCHLORIDE

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                                                                  TABLET; ORAL
                                                                  100MG
                                                                  1982-01-01
                                                                  86146
                                                                  AMITRIPTYLINE HYDR...
                                                                  DISCN
                                                                  No
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                                                                    AMITRIPTYLINE HYDROCHLORIDE

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                                                                    TABLET; ORAL
                                                                    75MG
                                                                    1982-01-01
                                                                    86147
                                                                    AMITRIPTYLINE HYDR...
                                                                    DISCN
                                                                    No
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                                                                      AMITRIPTYLINE HYDROCHLORIDE

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                                                                      TABLET; ORAL
                                                                      150MG
                                                                      1982-01-01
                                                                      86148
                                                                      AMITRIPTYLINE HYDR...
                                                                      DISCN
                                                                      No
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                                                                        ANAGRELIDE HYDROCHLORIDE

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                                                                        CAPSULE; ORAL
                                                                        EQ 0.5MG BASE
                                                                        2005-04-18
                                                                        76489
                                                                        ANAGRELIDE HYDROCH...
                                                                        DISCN
                                                                        No
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                                                                          ANAGRELIDE HYDROCHLORIDE

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                                                                          CAPSULE; ORAL
                                                                          EQ 1MG BASE
                                                                          2005-04-18
                                                                          76489
                                                                          ANAGRELIDE HYDROCH...
                                                                          DISCN
                                                                          No
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                                                                            ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

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                                                                            TABLET; ORAL
                                                                            325MG;2.25MG;0.19M...
                                                                            1982-06-04
                                                                            87742
                                                                            OXYCODONE AND ASPI...
                                                                            DISCN
                                                                            No
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                                                                              ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

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                                                                              TABLET; ORAL
                                                                              325MG;4.5MG;0.38MG
                                                                              1982-06-04
                                                                              87743
                                                                              ROXIPRIN
                                                                              DISCN
                                                                              No
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                                                                                ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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                                                                                TABLET; ORAL
                                                                                0.025MG;2.5MG
                                                                                1982-01-01
                                                                                86057
                                                                                DIPHENOXYLATE HYDR...
                                                                                DISCN
                                                                                No
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                                                                                  BICALUTAMIDE

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                                                                                  TABLET; ORAL
                                                                                  50MG
                                                                                  2011-03-24
                                                                                  78285
                                                                                  BICALUTAMIDE
                                                                                  DISCN
                                                                                  No
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                                                                                    CHLORDIAZEPOXIDE HYDROCHLORIDE

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                                                                                    CAPSULE; ORAL
                                                                                    10MG
                                                                                    1982-01-01
                                                                                    84700
                                                                                    CHLORDIAZEPOXIDE H...
                                                                                    DISCN
                                                                                    No
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                                                                                      CHLORDIAZEPOXIDE HYDROCHLORIDE

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                                                                                      CAPSULE; ORAL
                                                                                      25MG
                                                                                      1982-01-01
                                                                                      84705
                                                                                      CHLORDIAZEPOXIDE H...
                                                                                      DISCN
                                                                                      No
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                                                                                        CHLORDIAZEPOXIDE HYDROCHLORIDE

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                                                                                        CAPSULE; ORAL
                                                                                        5MG
                                                                                        1982-01-01
                                                                                        84706
                                                                                        CHLORDIAZEPOXIDE H...
                                                                                        DISCN
                                                                                        No
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                                                                                          CHLORPHENIRAMINE MALEATE

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                                                                                          TABLET; ORAL
                                                                                          4MG
                                                                                          1982-01-01
                                                                                          80626
                                                                                          CHLORPHENIRAMINE M...
                                                                                          DISCN
                                                                                          No
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                                                                                            CITALOPRAM HYDROBROMIDE

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                                                                                            TABLET; ORAL
                                                                                            EQ 10MG BASE
                                                                                            2004-11-23
                                                                                            77041
                                                                                            CITALOPRAM HYDROBR...
                                                                                            DISCN
                                                                                            No
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                                                                                              CITALOPRAM HYDROBROMIDE

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                                                                                              TABLET; ORAL
                                                                                              EQ 20MG BASE
                                                                                              2004-11-23
                                                                                              77041
                                                                                              CITALOPRAM HYDROBR...
                                                                                              DISCN
                                                                                              No
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                                                                                                CITALOPRAM HYDROBROMIDE

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                                                                                                TABLET; ORAL
                                                                                                EQ 40MG BASE
                                                                                                2004-11-23
                                                                                                77041
                                                                                                CITALOPRAM HYDROBR...
                                                                                                DISCN
                                                                                                No
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                                                                                                  CROMOLYN SODIUM

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                                                                                                  SOLUTION; INHALATI...
                                                                                                  10MG/ML
                                                                                                  1999-09-30
                                                                                                  75175
                                                                                                  CROMOLYN SODIUM
                                                                                                  DISCN
                                                                                                  No
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                                                                                                    CYCLOPHOSPHAMIDE

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                                                                                                    TABLET; ORAL
                                                                                                    25MG
                                                                                                    1999-08-17
                                                                                                    40032
                                                                                                    CYCLOPHOSPHAMIDE
                                                                                                    DISCN
                                                                                                    No
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                                                                                                      CYCLOPHOSPHAMIDE

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                                                                                                      TABLET; ORAL
                                                                                                      50MG
                                                                                                      1999-08-17
                                                                                                      40032
                                                                                                      CYCLOPHOSPHAMIDE
                                                                                                      DISCN
                                                                                                      No
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                                                                                                        DEXAMETHASONE

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                                                                                                        TABLET; ORAL
                                                                                                        0.25MG
                                                                                                        1982-01-01
                                                                                                        84614
                                                                                                        DEXAMETHASONE
                                                                                                        DISCN
                                                                                                        No
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