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Serving leading biopharmaceutical companies globally:

Citi
Dow
Fuji
UBS
Daiichi Sankyo
Chubb
Express Scripts
Deloitte
US Department of Justice
Boehringer Ingelheim

Generated: October 19, 2017

DrugPatentWatch Database Preview

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:
1
Applicant:
1
Ingredient:
1
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 2004► Subscribe► Subscribe
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 2004► Subscribe► Subscribe
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 2004► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
McKesson
Citi
Express Scripts
UBS
McKinsey
Cipla
Cerilliant
Fish and Richardson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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