Ofloxacin Ophthalmic (Page 3 of 3)

HOW SUPPLIED

Ofloxacin ophthalmic solution 0.3% is supplied sterile in plastic dropper bottles with tan caps in the following sizes:

5mL — NDC 60505-0560-0

10mL — NDC 60505-0560-1

Store at 25°C (77°F); excursions permitted 15 — 30°C (59 — 86°F).

Manufactured by: Manufactured for:

Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, FL 33326

Canada M9L 1T9

288421 August 2011

PRINCIPAL DISPLAY PANEL - 5 mL BOTTLE LABEL

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

APOTEX CORP. NDC 60505-0560-0

Ofloxacin Ophthalmic Solution USP

0.03%

Sterile Ophthalmic Solution

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

5 mL

ofloxacin-bottle
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL CARTON LABEL

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

APOTEX CORP. NDC 60505-0560-0

Ofloxacin Ophthalmic Solution USP

0.03%

Sterile Ophthalmic Solution

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

5 mL

ofloxacin-carton
(click image for full-size original)
OFLOXACIN OPHTHALMIC
ofloxacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0560
Route of Administration OPHTHALMIC 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
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0560-0 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60505-0560-0)
2 NDC:60505-0560-1 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60505-0560-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076513 05/14/2004
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 255092496 manufacture (60505-0560), analysis (60505-0560)

Revised: 09/2012 Apotex Corp.

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