PRED-GATI- prednisolone acetate-gatifloxacin 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 
prednisolone acetate-gatifloxacin suspension/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-502
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A) GATIFLOXACIN5 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:71384-502-0320 in 1 BOX01/05/201807/01/2019
13.5 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 other01/05/201807/01/2019
Labeler - Imprimis NJOF, LLC (080431967)

Revised: 2/2020
Document Id: 9e644a66-cd85-50f5-e053-2995a90a227b
Set id: 6326b43a-bbac-4696-e053-2a91aa0a73fb
Version: 3
Effective Time: 20200212
 
Imprimis NJOF, LLC