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

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    SHIRE PLC
    Ireland Flag
    Country
    Country
    Ireland
    Address
    Address
    No. 99854 22 Grenville Street St Helier Jersey JE4 8PX
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    Telephone
    +353 1 429 7700
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    enquiries@pharmacompass.com
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    https://www.shire.com/
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    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

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    CAPSULE; ORAL
    325MG;50MG;40MG
    1986-10-01
    87628
    ANOQUAN
    DISCN
    No
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      AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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      TABLET; ORAL
      25MG;2MG **Federal...
      1982-01-01
      14715
      TRIAVIL 2-25
      DISCN
      No
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        AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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        TABLET; ORAL
        10MG;4MG **Federal...
        1982-01-01
        14715
        TRIAVIL 4-10
        DISCN
        No
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          AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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          TABLET; ORAL
          10MG;2MG **Federal...
          1982-01-01
          14715
          TRIAVIL 2-10
          DISCN
          No
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            AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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            TABLET; ORAL
            25MG;4MG **Federal...
            1982-01-01
            14715
            TRIAVIL 4-25
            DISCN
            No
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              AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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              TABLET; ORAL
              50MG;4MG **Federal...
              1982-01-01
              14715
              TRIAVIL 4-50
              DISCN
              No
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              DEXTROAMPHETAMINE SULFATE

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              TABLET; ORAL
              5MG **Federal Regi...
              1982-01-01
              84051
              DEXTROSTAT
              DISCN
              Yes
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              DEXTROAMPHETAMINE SULFATE

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              TABLET; ORAL
              10MG **Federal Reg...
              1982-01-01
              84051
              DEXTROSTAT
              DISCN
              Yes
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                DOXEPIN HYDROCHLORIDE

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                CAPSULE; ORAL
                EQ 10MG BASE
                1982-01-01
                16987
                DOXEPIN HYDROCHLOR...
                DISCN
                No
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                  DOXEPIN HYDROCHLORIDE

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                  CAPSULE; ORAL
                  EQ 25MG BASE
                  1982-01-01
                  16987
                  DOXEPIN HYDROCHLOR...
                  DISCN
                  No
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                    DOXEPIN HYDROCHLORIDE

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                    CAPSULE; ORAL
                    EQ 50MG BASE
                    1982-01-01
                    16987
                    DOXEPIN HYDROCHLOR...
                    DISCN
                    No
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                      DOXEPIN HYDROCHLORIDE

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                      CAPSULE; ORAL
                      EQ 100MG BASE
                      1982-01-01
                      16987
                      DOXEPIN HYDROCHLOR...
                      DISCN
                      No
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                        DOXEPIN HYDROCHLORIDE

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                        CAPSULE; ORAL
                        EQ 75MG BASE
                        1982-01-01
                        16987
                        DOXEPIN HYDROCHLOR...
                        DISCN
                        No
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                          DOXEPIN HYDROCHLORIDE

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                          CAPSULE; ORAL
                          EQ 150MG BASE
                          1987-04-13
                          16987
                          DOXEPIN HYDROCHLOR...
                          DISCN
                          No
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                            FERRIC OXYHYDROXIDE

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                            INJECTABLE; INJECT...
                            EQ 50MG IRON/ML
                            1982-01-01
                            17807
                            PROFERDEX
                            DISCN
                            No
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                            FURAZOLIDONE

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                            TABLET; ORAL
                            100MG
                            1982-01-01
                            11270
                            FUROXONE
                            DISCN
                            No
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                            FURAZOLIDONE

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                            SUSPENSION; ORAL
                            50MG/15ML
                            1982-01-01
                            11323
                            FUROXONE
                            DISCN
                            No
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                            HISTRELIN ACETATE

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                            INJECTABLE; INJECT...
                            EQ 0.2MG BASE/ML
                            1991-12-24
                            19836
                            SUPPRELIN
                            DISCN
                            No
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                            HISTRELIN ACETATE

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                            INJECTABLE; INJECT...
                            EQ 0.5MG BASE/ML
                            1991-12-24
                            19836
                            SUPPRELIN
                            DISCN
                            No
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                            HISTRELIN ACETATE

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                            INJECTABLE; INJECT...
                            EQ 1MG BASE/ML
                            1991-12-24
                            19836
                            SUPPRELIN
                            DISCN
                            No
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                            • FDA
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                            HYDROFLUMETHIAZIDE

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                            TABLET; ORAL
                            50MG
                            1982-01-01
                            11949
                            SALURON
                            DISCN
                            Yes
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                            HYDROFLUMETHIAZIDE; RESERPINE

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                            TABLET; ORAL
                            50MG;0.125MG
                            1982-01-01
                            12359
                            SALUTENSIN
                            DISCN
                            No
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                            HYDROFLUMETHIAZIDE; RESERPINE

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                            TABLET; ORAL
                            25MG;0.125MG
                            1982-01-01
                            12359
                            SALUTENSIN-DEMI
                            DISCN
                            No
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                            IDURSULFASE

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                            INJECTABLE; IV (I...
                            6MG/3ML
                            125151
                            ELAPRASE
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                            • FDA
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                            LEVODOPA

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                            CAPSULE; ORAL
                            250MG
                            1982-01-01
                            16913
                            DOPAR
                            DISCN
                            No
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                            LEVODOPA

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                            CAPSULE; ORAL
                            500MG
                            1982-01-01
                            16913
                            DOPAR
                            DISCN
                            No
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                            LEVODOPA

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                            CAPSULE; ORAL
                            100MG
                            1982-01-01
                            16913
                            DOPAR
                            DISCN
                            No
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                            LEVODOPA

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                            TABLET; ORAL
                            250MG
                            1982-01-01
                            16913
                            DOPAR
                            DISCN
                            No
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                            LEVODOPA

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                            TABLET; ORAL
                            500MG
                            1982-01-01
                            16913
                            DOPAR
                            DISCN
                            No
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                            METHANTHELINE BROMIDE

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                            TABLET; ORAL
                            50MG
                            1982-01-01
                            7390
                            BANTHINE
                            DISCN
                            No
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                            MORICIZINE HYDROCHLORIDE

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                            TABLET; ORAL
                            200MG
                            1990-06-19
                            19753
                            ETHMOZINE
                            DISCN
                            No
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                            MORICIZINE HYDROCHLORIDE

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                            TABLET; ORAL
                            250MG
                            1990-06-19
                            19753
                            ETHMOZINE
                            DISCN
                            No
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                            MORICIZINE HYDROCHLORIDE

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                            TABLET; ORAL
                            300MG
                            1990-06-19
                            19753
                            ETHMOZINE
                            DISCN
                            No
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                            NITROFURAZONE

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                            OINTMENT; TOPICAL
                            0.2%
                            1982-01-01
                            5795
                            FURACIN
                            DISCN
                            No
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                            NITROFURAZONE

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                            CREAM; TOPICAL
                            0.2%
                            1982-01-01
                            83789
                            FURACIN
                            DISCN
                            No
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                            NITROFURAZONE

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                            POWDER; TOPICAL
                            0.2%
                            1982-01-01
                            83791
                            FURACIN
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            TABLET; ORAL
                            35MG
                            1982-01-01
                            86550
                            X-TROZINE
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            TABLET; ORAL
                            35MG
                            1982-01-01
                            86551
                            X-TROZINE
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            TABLET; ORAL
                            35MG
                            1982-01-01
                            86552
                            X-TROZINE
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            TABLET; ORAL
                            35MG
                            1982-01-01
                            86553
                            X-TROZINE
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            TABLET; ORAL
                            35MG
                            1982-01-01
                            86554
                            X-TROZINE
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            CAPSULE, EXTENDED ...
                            105MG
                            1982-08-24
                            87371
                            X-TROZINE L.A.
                            DISCN
                            No
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                            PHENDIMETRAZINE TARTRATE

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                            CAPSULE; ORAL
                            35MG
                            1982-09-22
                            87394
                            X-TROZINE
                            DISCN
                            No
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                            PHENTERMINE HYDROCHLORIDE

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                            CAPSULE; ORAL
                            30MG
                            1982-03-18
                            87764
                            OBY-TRIM
                            DISCN
                            No
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                            PROPANTHELINE BROMIDE

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                            TABLET; ORAL
                            15MG **Federal Reg...
                            1982-01-01
                            8732
                            PRO-BANTHINE
                            DISCN
                            Yes
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                            PROPANTHELINE BROMIDE

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                            TABLET; ORAL
                            7.5MG **Federal Re...
                            1982-01-01
                            8732
                            PRO-BANTHINE
                            DISCN
                            Yes
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                            TETRACYCLINE HYDROCHLORIDE

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                            FOR SOLUTION; TOPI...
                            2.2MG/ML
                            1982-01-01
                            50493
                            TOPICYCLINE
                            DISCN
                            No
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                            URACIL MUSTARD

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                            CAPSULE; ORAL
                            1MG
                            1982-01-01
                            12892
                            URACIL MUSTARD
                            DISCN
                            No
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                            VELAGLUCERASE ALFA

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                            INJECTABLE; INTRAV...
                            400 UNITS/VIAL
                            22575
                            VPRIV
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                            VELAGLUCERASE ALFA

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                            POWDER; INTRAVENOU...
                            200 UNITS/VIAL
                            22575
                            VPRIV
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