PRED-GATI-BROM- prednisolone-gatifloxacin-bromfenac suspension/ drops 
ImprimisRx NJ

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.

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Store at 20° to 25° C (68° to 77° F)

Bottle Label

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)

Revised: 2/2018
Document Id: 65d1a00a-54fc-5afd-e053-2991aa0a69a9
Set id: 65d1a00a-54fb-5afd-e053-2991aa0a69a9
Version: 1
Effective Time: 20180222
 
ImprimisRx NJ