PRED-BROM- prednisolone acetate-bromfenac 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.

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Store at 20° to 25° C (68° to 77° F)

Bottle Label

PRED-BROM 
prednisolone acetate-bromfenac suspension/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70261-505
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 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:70261-505-033.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2018
Labeler - ImprimisRx NJ (931390178)

Revised: 3/2018
Document Id: 66638e3d-e2aa-e7c5-e053-2a91aa0ae8c0
Set id: 66638e3d-e2a9-e7c5-e053-2a91aa0ae8c0
Version: 1
Effective Time: 20180301
 
ImprimisRx NJ