PRED-GATI-BROM- prednisolone acetate-gatifloxacin-bromfenac suspension/ drops 
Imprimis NJOF, LLC

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)

Package Label

Package Label

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 BOX01/12/201807/01/2019
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 other01/12/201807/01/2019
Labeler - Imprimis NJOF, LLC (080431967)

Revised: 2/2020
Document Id: 9e6432d1-ab3e-05b1-e053-2995a90a66f8
Set id: 6316c561-8cd1-fe74-e053-2991aa0aef5f
Version: 3
Effective Time: 20200212
 
Imprimis NJOF, LLC