PRED-GATI- prednisolone-gatifloxacin suspension 
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.

----------

Store at 20° to 25° C (68° to 77° F)

Bottle Label

Bottle Label

PRED-GATI 
prednisolone-gatifloxacin suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70261-502
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
GATIFLOXACIN HEMIHYDRATE (UNII: AN201CY09J) (GATIFLOXACIN - UNII:L4618BD7KJ) GATIFLOXACIN HEMIHYDRATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) 1.9 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70261-502-033.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/2018
Labeler - ImprimisRx NJ (931390178)

Revised: 2/2018
Document Id: 65d1ebbd-b3d4-59ca-e053-2991aa0a1874
Set id: 65346afa-45cf-9f3b-e053-2991aa0ac8b1
Version: 2
Effective Time: 20180222
 
ImprimisRx NJ