Pred-Gati-Brom

PRED-GATI-BROM- gatifloxacin hemihydrate, bromfenac and prednisolone acetate suspension/ drops
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
(click image for full-size original)

PRED-GATI-BROM
prednisolone-gatifloxacin-bromfenac suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70261-504
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GATIFLOXACIN HEMIHYDRATE (GATIFLOXACIN) GATIFLOXACIN HEMIHYDRATE 5 mg in 1 mL
BROMFENAC (BROMFENAC) BROMFENAC 0.75 mg in 1 mL
PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70261-504-03 3.5 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2018
Labeler — ImprimisRx NJ (931390178)

Revised: 02/2018 ImprimisRx NJ

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