Label: PRED-GATI-BROM- prednisolone-gatifloxacin-bromfenac suspension/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated February 22, 2018

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  • STORAGE AND HANDLING

    Store at 20° to 25° C (68° to 77° F)

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    PRED-GATI-BROM 
    prednisolone-gatifloxacin-bromfenac suspension/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70261-504
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GATIFLOXACIN HEMIHYDRATE (UNII: AN201CY09J) (GATIFLOXACIN - UNII:L4618BD7KJ) GATIFLOXACIN HEMIHYDRATE5 mg  in 1 mL
    BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 mg  in 1 mL
    PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70261-504-033.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2018
    Labeler - ImprimisRx NJ (931390178)
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