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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Express Scripts
Chinese Patent Office

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050616

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NDA 050616 describes TOBRADEX, which is a drug marketed by Novartis Pharms Corp and is included in three NDAs. It is available from five suppliers. There are three patents protecting this drug. Additional details are available on the TOBRADEX profile page.

The generic ingredient in TOBRADEX is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for 050616

Formulation / Manufacturing:see details

Pharmacology for NDA: 050616

Suppliers and Packaging for NDA: 050616

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dexamethasone; tobramycin
OINTMENT;OPHTHALMIC 050616 NDA Alcon Laboratories, Inc. 0065-0648 0065-0648-08 1 TUBE in 1 CARTON (0065-0648-08) > 3.5 g in 1 TUBE
dexamethasone; tobramycin
OINTMENT;OPHTHALMIC 050616 NDA Alcon Laboratories, Inc. 0065-0648 0065-0648-35 1 TUBE in 1 CARTON (0065-0648-35) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.1%;0.3%
Approval Date:Sep 28, 1988TE:RLD:Yes

Expired Orange Book Patents for NDA: 050616

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
dexamethasone; tobramycin
OINTMENT;OPHTHALMIC050616-001Sep 28, 1988► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
US Department of Justice
Daiichi Sankyo

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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