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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 24, 2018

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  • STORAGE AND HANDLING

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

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PRED-GATI-BROM 
    prednisolone acetate-gatifloxacin-bromfenac suspension/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-503
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMFENAC SODIUM (UNII: 8ECV571Y37) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 mg  in 1 mL
    PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
    GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A) GATIFLOXACIN5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-503-0720 in 1 BOX01/12/2018
    17 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/12/2018
    Labeler - Imprimis NJOF, LLC (080431967)