PRED PHOS-GATI-BROM- prednisolone phosphate - gatifloxacin - bromfenac solution/ 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)​

Bottle Label

PRED PHOS-GATI-BROM 
prednisolone phosphate - gatifloxacin - bromfenac solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-550
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE 21-PHOSPHATE10 mg  in 1 mL
GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A) GATIFLOXACIN5 mg  in 1 mL
BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71384-550-033.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/02/201807/01/2019
2NDC:71384-550-077 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/02/201807/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/02/201807/01/2019
Labeler - Imprimis NJOF, LLC (080431967)

Revised: 2/2020
Document Id: 9e644f55-0f3c-04b8-e053-2a95a90ab300
Set id: 6dd75810-da95-28aa-e053-2a91aa0a0dab
Version: 3
Effective Time: 20200212
 
Imprimis NJOF, LLC