GATI-DEX- gatifloxacin-dexamethasone phosphate 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)

Package Label

Package Label

GATI-DEX 
gatifloxacin-dexamethasone phosphate solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-506
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE SODIUM PHOSPHATE1 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:71384-506-0520 in 1 BOX01/05/201802/01/2019
15 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 other01/05/201802/01/2019
Labeler - Imprimis NJOF, LLC (080431967)

Revised: 2/2020
Document Id: 9e63103b-ebd8-9a42-e053-2995a90aee47
Set id: 6325d560-cd47-fc9b-e053-2991aa0a719e
Version: 3
Effective Time: 20200212
 
Imprimis NJOF, LLC