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

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      ACETAMINOPHEN; IBUPROFEN

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      TABLET; ORAL
      250MG;125MG
      2023-08-01
      216999
      ACETAMINOPHEN AND ...
      OTC
      No
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        AMANTADINE HYDROCHLORIDE

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        CAPSULE; ORAL
        100MG
        2008-05-29
        78720
        AMANTADINE HYDROCH...
        RX
        No
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          AMPHETAMINE SULFATE

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          TABLET; ORAL
          5MG
          2019-11-22
          212919
          AMPHETAMINE SULFAT...
          RX
          No
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            AMPHETAMINE SULFATE

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            TABLET; ORAL
            10MG
            2019-11-22
            212919
            AMPHETAMINE SULFAT...
            RX
            No
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              APIXABAN

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              TABLET; ORAL
              2.5MG
              2020-04-08
              210152
              APIXABAN
              DISCN
              No
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                APIXABAN

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                TABLET; ORAL
                5MG
                2020-04-08
                210152
                APIXABAN
                DISCN
                No
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                  ATOVAQUONE

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                  SUSPENSION; ORAL
                  750MG/5ML
                  2021-03-30
                  212918
                  ATOVAQUONE
                  RX
                  No
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                    AZELASTINE HYDROCHLORIDE

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                    SPRAY, METERED; NA...
                    0.137MG/SPRAY
                    2015-07-28
                    90176
                    AZELASTINE HYDROCH...
                    RX
                    No
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                      AZITHROMYCIN

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                      TABLET; ORAL
                      EQ 600MG BASE
                      2018-12-26
                      209999
                      AZITHROMYCIN
                      RX
                      No
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                        AZITHROMYCIN

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                        TABLET; ORAL
                        EQ 250MG BASE
                        2019-02-26
                        210000
                        AZITHROMYCIN
                        RX
                        No
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                          AZITHROMYCIN

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                          TABLET; ORAL
                          EQ 500MG BASE
                          2019-02-26
                          210001
                          AZITHROMYCIN
                          RX
                          No
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                            BENZONATATE

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                            CAPSULE; ORAL
                            100MG
                            1993-01-29
                            81297
                            BENZONATATE
                            RX
                            No
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                              BENZONATATE

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                              CAPSULE; ORAL
                              200MG
                              2007-10-30
                              81297
                              BENZONATATE
                              RX
                              No
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                                BEXAROTENE

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                                CAPSULE; ORAL
                                75MG
                                2014-08-12
                                203174
                                BEXAROTENE
                                RX
                                No
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                                  BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

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                                  SYRUP; ORAL
                                  2MG/5ML;10MG/5ML;3...
                                  2020-09-30
                                  203997
                                  BROMPHENIRAMINE MA...
                                  DISCN
                                  No
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                                    CALCITRIOL

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                                    CAPSULE; ORAL
                                    0.25MCG
                                    2013-05-24
                                    91174
                                    CALCITRIOL
                                    RX
                                    No
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                                      CALCITRIOL

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                                      CAPSULE; ORAL
                                      0.5MCG
                                      2013-05-24
                                      91174
                                      CALCITRIOL
                                      RX
                                      No
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                                        CARBAMAZEPINE

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                                        TABLET; ORAL
                                        200MG
                                        2024-02-16
                                        218221
                                        CARBAMAZEPINE
                                        RX
                                        No
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                                          CETIRIZINE HYDROCHLORIDE

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                                          CAPSULE; ORAL
                                          5MG
                                          2009-07-23
                                          22429
                                          CETIRIZINE HYDROCH...
                                          OTC
                                          Yes
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                                            CETIRIZINE HYDROCHLORIDE

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                                            CAPSULE; ORAL
                                            10MG
                                            2009-07-23
                                            22429
                                            CETIRIZINE HYDROCH...
                                            OTC
                                            Yes
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                                              CETIRIZINE HYDROCHLORIDE

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                                              CAPSULE; ORAL
                                              5MG
                                              2009-07-23
                                              22429
                                              CETIRIZINE HYDROCH...
                                              OTC
                                              Yes
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                                                CETIRIZINE HYDROCHLORIDE

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                                                CAPSULE; ORAL
                                                10MG
                                                2009-07-23
                                                22429
                                                CETIRIZINE HYDROCH...
                                                OTC
                                                Yes
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                                                  CETIRIZINE HYDROCHLORIDE

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                                                  SOLUTION; ORAL
                                                  5MG/5ML
                                                  2008-10-06
                                                  78488
                                                  CETIRIZINE HYDROCH...
                                                  RX
                                                  No
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                                                    CEVIMELINE HYDROCHLORIDE

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                                                    CAPSULE; ORAL
                                                    30MG
                                                    2023-11-08
                                                    218290
                                                    CEVIMELINE HYDROCH...
                                                    RX
                                                    No
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                                                      CLOBAZAM

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                                                      SUSPENSION; ORAL
                                                      2.5MG/ML
                                                      2018-10-22
                                                      208819
                                                      CLOBAZAM
                                                      RX
                                                      No
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                                                        CLOBAZAM

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                                                        TABLET; ORAL
                                                        10MG
                                                        2018-10-22
                                                        208825
                                                        CLOBAZAM
                                                        RX
                                                        No
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                                                          CLOBAZAM

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                                                          TABLET; ORAL
                                                          20MG
                                                          2018-10-22
                                                          208825
                                                          CLOBAZAM
                                                          RX
                                                          No
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                                                            COLESEVELAM HYDROCHLORIDE

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                                                            TABLET; ORAL
                                                            625MG
                                                            2019-09-13
                                                            208670
                                                            COLESEVELAM HYDROC...
                                                            RX
                                                            No
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                                                              DEFERASIROX

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                                                              TABLET, FOR SUSPEN...
                                                              125MG
                                                              2019-11-20
                                                              210920
                                                              DEFERASIROX
                                                              RX
                                                              No
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                                                                DEFERASIROX

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                                                                TABLET, FOR SUSPEN...
                                                                250MG
                                                                2019-11-20
                                                                210920
                                                                DEFERASIROX
                                                                RX
                                                                No
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                                                                  DEFERASIROX

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                                                                  TABLET, FOR SUSPEN...
                                                                  500MG
                                                                  2019-11-20
                                                                  210920
                                                                  DEFERASIROX
                                                                  RX
                                                                  No
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                                                                    DEXAMETHASONE

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                                                                    TABLET; ORAL
                                                                    4MG
                                                                    2023-04-19
                                                                    217001
                                                                    DEXAMETHASONE
                                                                    RX
                                                                    No
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                                                                      DEXAMETHASONE

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                                                                      TABLET; ORAL
                                                                      6MG
                                                                      2023-04-19
                                                                      217001
                                                                      DEXAMETHASONE
                                                                      RX
                                                                      No
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                                                                        DEXAMETHASONE

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                                                                        TABLET; ORAL
                                                                        2MG
                                                                        2023-04-26
                                                                        217538
                                                                        DEXAMETHASONE
                                                                        RX
                                                                        No
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                                                                          DEXMETHYLPHENIDATE HYDROCHLORIDE

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                                                                          TABLET; ORAL
                                                                          5MG
                                                                          2020-03-24
                                                                          209754
                                                                          DEXMETHYLPHENIDATE...
                                                                          DISCN
                                                                          No
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                                                                            DEXMETHYLPHENIDATE HYDROCHLORIDE

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                                                                            TABLET; ORAL
                                                                            10MG
                                                                            2020-03-24
                                                                            209754
                                                                            DEXMETHYLPHENIDATE...
                                                                            DISCN
                                                                            No
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                                                                              DICLOFENAC POTASSIUM

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                                                                              CAPSULE; ORAL
                                                                              25MG
                                                                              2016-02-23
                                                                              204648
                                                                              DICLOFENAC POTASSI...
                                                                              RX
                                                                              No
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                                                                                DICYCLOMINE HYDROCHLORIDE

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                                                                                TABLET; ORAL
                                                                                20MG
                                                                                2023-08-04
                                                                                217916
                                                                                DICYCLOMINE HYDROC...
                                                                                RX
                                                                                No
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                                                                                  DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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                                                                                  CAPSULE; ORAL
                                                                                  25MG;EQ 200MG FREE...
                                                                                  2010-11-22
                                                                                  90397
                                                                                  IBUPROFEN AND DIPH...
                                                                                  OTC
                                                                                  No
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                                                                                    DOFETILIDE

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                                                                                    CAPSULE; ORAL
                                                                                    0.125MG
                                                                                    2018-04-10
                                                                                    208625
                                                                                    DOFETILIDE
                                                                                    RX
                                                                                    No
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                                                                                      DOFETILIDE

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                                                                                      CAPSULE; ORAL
                                                                                      0.25MG
                                                                                      2018-04-10
                                                                                      208625
                                                                                      DOFETILIDE
                                                                                      RX
                                                                                      No
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                                                                                        DOFETILIDE

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                                                                                        CAPSULE; ORAL
                                                                                        0.5MG
                                                                                        2018-04-10
                                                                                        208625
                                                                                        DOFETILIDE
                                                                                        RX
                                                                                        No
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                                                                                          DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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                                                                                          TABLET, DELAYED RE...
                                                                                          10MG;10MG
                                                                                          2023-08-04
                                                                                          217000
                                                                                          DOXYLAMINE SUCCINA...
                                                                                          RX
                                                                                          No
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                                                                                            DROXIDOPA

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                                                                                            CAPSULE; ORAL
                                                                                            100MG
                                                                                            2021-04-28
                                                                                            213033
                                                                                            DROXIDOPA
                                                                                            RX
                                                                                            No
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                                                                                              DROXIDOPA

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                                                                                              CAPSULE; ORAL
                                                                                              200MG
                                                                                              2021-04-28
                                                                                              213033
                                                                                              DROXIDOPA
                                                                                              RX
                                                                                              No
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                                                                                                DROXIDOPA

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                                                                                                CAPSULE; ORAL
                                                                                                300MG
                                                                                                2021-04-28
                                                                                                213033
                                                                                                DROXIDOPA
                                                                                                RX
                                                                                                No
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                                                                                                  DUTASTERIDE

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                                                                                                  CAPSULE; ORAL
                                                                                                  0.5MG
                                                                                                  2015-11-20
                                                                                                  200899
                                                                                                  DUTASTERIDE
                                                                                                  RX
                                                                                                  No
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                                                                                                    ENALAPRIL MALEATE

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                                                                                                    SOLUTION; ORAL
                                                                                                    1MG/ML
                                                                                                    2021-08-10
                                                                                                    212408
                                                                                                    ENALAPRIL MALEATE
                                                                                                    RX
                                                                                                    No
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                                                                                                      ERGOCALCIFEROL

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                                                                                                      CAPSULE; ORAL
                                                                                                      50,000 IU
                                                                                                      1982-01-01
                                                                                                      80704
                                                                                                      VITAMIN D
                                                                                                      RX
                                                                                                      No
                                                                                                      AA
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                                                                                                        ETHOSUXIMIDE

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                                                                                                        CAPSULE; ORAL
                                                                                                        250MG
                                                                                                        2002-10-28
                                                                                                        40430
                                                                                                        ETHOSUXIMIDE
                                                                                                        RX
                                                                                                        No
                                                                                                        AB
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