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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 one supplier. Additional details are available on the ZYLET profile page.

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

Summary for NDA: 050804

Tradename:
ZYLET
Applicant:
Bausch And Lomb
Ingredient:
loteprednol etabonate; tobramycin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050804

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%;0.3%
Approval Date:Dec 14, 2004TE:RLD:Yes

Expired Orange Book 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;OPHTHALMIC050804-001Dec 14, 20044,996,335*PED► subscribe
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 20045,747,061*PED► subscribe
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 20045,540,930*PED► subscribe
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