STRENZA- moxifloxacin 0.5%, ketorolac tromethamine 0.5%, prednisolone acetate 1% kit

STRENZA by

Drug Labeling and Warnings

STRENZA by is a Prescription medication manufactured, distributed, or labeled by Brisk Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Rx Only

NDC: 73614-731-03

For Use in Eyes Only

STRENZA tm

Each Pack Contains:

Moxifloxacin Ophthalmic Solution, USP 0.5% - 3ml Bottle

Ketorolac Tromethamine Ophthalmic Solution, 0.5% - 5ml Bottle
Prednisolone Acetate Ophthalmic Suspension, USP 1% - 5ml Bottle

Brisk Pharmaceuticals

DESCRIPTION

Keep out of the reach of children.

TAMPER EVIDENT: Do not use the individual
eye drops inside the pack if the seal on its
bottle is broken or missing.

Lot: See the lot number on each individual
bottle inside the pack.
Exp: See the expiration date on each
individual bottle inside the pack.

Packaged by:
Unit Dose Solutions Inc.,
Morrisville, NC 27560
Distributed by:
Brisk pharmaceuticals,
Richardson, TX 75081

PATIENT MEDICATION INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRENZA 
moxifloxacin 0.5%, ketorolac tromethamine 0.5%, prednisolone acetate 1% kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73614-731

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-731-03	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	10/16/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	5 mL
Part 2	1 BOTTLE, PLASTIC	5 mL
Part 3	1 BOTTLE	3 mL

Part 1 of 3

KETOROLAC TROMETHAMINE 
ketorolac tromethamine solution/ drops

Product Information
Item Code (Source)	NDC: 69315-322
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC TROMETHAMINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OCTOXYNOL-40 (UNII: 9T1C662FKS)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218204	06/01/2024

Part 2 of 3

PREDNISOLONE ACETATE 
prednisolone acetate suspension/ drops

Product Information
Item Code (Source)	NDC: 61314-637
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)	PREDNISOLONE ACETATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA017469	12/15/1994

Part 3 of 3

MOXIFLOXACIN 
moxifloxacin solution/ drops

Product Information
Item Code (Source)	NDC: 68180-422
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P)	MOXIFLOXACIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow (Yellow Colored Transparent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202867	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/16/2024

Labeler - Brisk Pharmaceuticals (117250794)