Details for New Drug Application (NDA): 050804

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NDA 050804 describes ZYLET, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. Additional details are available on the ZYLET profile page.

The generic ingredient in ZYLET is loteprednol etabonate; tobramycin. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the loteprednol etabonate; tobramycin profile page.

Summary for 050804

Tradename:	ZYLET
Applicant:	Bausch And Lomb
Ingredient:	loteprednol etabonate; tobramycin
Patents:	0

Pharmacology for NDA: 050804

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 050804

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804	NDA	Bausch & Lomb Incorporated	24208-358	24208-358-01	1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER
ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804	NDA	Bausch & Lomb Incorporated	24208-358	24208-358-05	1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.5%;0.3%
Approval Date:	Dec 14, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050804

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804-001	Dec 14, 2004	4,996,335*PED	⤷ Start Trial
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804-001	Dec 14, 2004	5,540,930*PED	⤷ Start Trial
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804-001	Dec 14, 2004	5,747,061*PED	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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