Ofloxacin Otic (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.3% Bottle Label

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-0363-1

Ofloxacin Otic Solution

0.3%

Rx

5 mL Bottle Label

oflox-bottle-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3% Carton Label

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-0363-1

Ofloxacin Otic Solution

0.3%

Rx

5 mL Carton Label

oflox-ctn-label
(click image for full-size original)
OFLOXACIN OTIC
ofloxacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0363
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFLOXACIN (OFLOXACIN) OFLOXACIN 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0363-1 5 mL in 1 BOTTLE, DROPPER None
2 NDC:60505-0363-2 10 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076527 05/14/2004
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 255092496 manufacture (60505-0363), analysis (60505-0363)

Revised: 01/2018 Apotex Corp.

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